Effectiveness of Chest Physiotherapy in Infants

Hospitalized with Acute Bronchiolitis: A Multicenter,

Randomized, Controlled Trial
Vincent Gajdos1,2,3*, Sandrine Katsahian4,5, Nicole Beydon6, Ve´ ronique Abadie7,8, Loı¨c de Pontual9,10,
Sophie Larrar3,11, Ralph Epaud12,13, Bertrand Chevallier14,15, Sylvain Bailleux1, Alix Mollet-Boudjemline 1,
Jean Bouyer2,3, Sylvie Chevret4,5, Philippe Labrune1,3
1 Assistance Publique – Hoˆ pitaux de Paris (APHP), Pediatric Department, Hoˆ pital Antoine Be´ cle` re, Clamart, France, 2 Inserm, CESP Centre for Research in
Epidemiology and Population Health, U1018, Reproduction and Child Development Team, Villejuif, France, 3 Universite´ Paris Sud 11, Paris, France, 4 APHP, Biostatistic
Department, Hoˆ pital Saint Louis, Paris, France, 5 Inserm UMRS U717, Paris, France, 6 APHP, Pulmonology Unit, Pediatric Department, Robert Debre´ Hospital,
Paris, France, 7 Pediatric Department, Hoˆ pital Necker Enfants Malades, Paris, France, 8 Universite´ Paris 5, Paris, France, 9 APHP, Pediatric Department,
Hoˆ pital Jean Verdier, Bondy, France, 10 Universite´ Paris Nord, Bobigny, France, 11 APHP, Pediatric Emergency Department, Necker Enfants Malades, Paris, France,
12 APHP, Pediatric Department, Hoˆ pital Armand Trousseau, Paris, France, 13 Universite´ Paris 6, Paris, France, 14 APHP, Pediatric Department, Hoˆ pital Ambroise
Pare´, Boulogne, France, 15 Universite´ Versailles, Saint Quentin en Yvelines, France

Abstract
Background: Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is
routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy
combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the
efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute
bronchiolitis.

Methods and Findings: We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in
seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis
between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times
a day, either IET + AC (intervention group, n= 246) or nasal suction (NS, control group, n= 250). Only
physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined
as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than
two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation,
antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical
analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval
[CI] 1.97–2.73) for the control group and 2.02 days (95% CI 1.96–2.34) for the intervention group, indicating no
significant effect of physiotherapy (hazard ratio [HR] = 1.09, 95% CI 0.91–1.31, p= 0.33). No treatment by age
interaction was found (p= 0.97). Frequency of vomiting and transient respiratory destabilization was higher in the
IET + AC group during the procedure (relative risk [RR] = 10.2, 95% CI 1.3–78.8, p= 0.005 and RR = 5.4, 95% CI 1.6–
18.4, p= 0.002, respectively). No difference between groups in bradycardia with or without desaturation (RR = 1.0, 95%
CI 0.2–5.0, p= 1.00 and RR = 3.6, 95% CI 0.7–16.9, p= 0.10, respectively) was found during the procedure. Parents
reported that the procedure was more arduous in the group treated with IET (mean difference = 0.88, 95% CI 0.33–
1.44, p= 0.002), whereas there was no difference regarding the assessment of the child’s comfort between both
groups (mean difference = 20.07, 95% CI 20.53 to 0.38, p = 0.40). No evidence of differences
between groups in intensive care admission (RR = 0.7, 95% CI 0.3–1.8, p= 0.62), ventilatory support (RR = 2.5, 95% CI
0.5–
13.0, p= 0.29), and antibiotic treatment (RR = 1.0, 95% CI 0.7–1.3, p= 1.00) was observed.

Conclusions: IET + AC had no significant effect on time to recovery in this group of hospitalized infants with
bronchiolitis. Additional studies are required to explore the effect of chest physiotherapy on ambulatory populations
and for infants without a history of atopy.

Trial registration: ClinicalTrials.gov NCT00125450

Please see later in the article for the Editors’ Summary.

PLoS Medicine | www.plosmedicine.org 1 September 2010 | Volume 7 | Issue 9 | e1000345

 Chest Physiotherapy in Acute Bronchiolitis

Citation: Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, et al. (2010) Effectiveness of Chest Physiotherapy in Infants Hospitalized with Acute Bronchiolitis: A Multicen
Academic Editor: Rosalind Louise Smyth, University of Liverpool, United Kingdom
Received April 15, 2010; Accepted August 19, 2010; Published September 28, 2010
Copyright: © 2010 Gajdos et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distributio
Funding: This work was supported by a grant from French Health Ministry (PHRC AOM 03/123) and by a grant from the Association des Re´seaux Bronchiolites (ARB). The fund
Competing Interests: All authors declare that (1) no financial support for the submitted work from anyone other than their employer; (2) no financial relationships with commercial
Abbreviations: AC, assisted cough; CI, confidence interval; HR, hazard ratio; IET, increased exhalation technique; IQR, interquartile range; NS, nasal suction; PICU, pediatric inte
* E-mail:
 Clamart; Jean Verdier, Bondy; Ambroise Pare´, Boulogne;
Introduction Kremlin Biceˆtre, Le Kremlin Biceˆtre; and Paris, Robert Debre´,
Necker Enfants Malades, and Armand Trousseau) during
Acute viral bronchiolitis is generally a self-limiting bronchiolitis outbreaks from October 2004 through January
condition and is most commonly associated with respiratory 2008 (Texts S1 and S2). Planned start and end dates were
syncytial virus (RSV) infection. It is the most common lower identical for all centers.
respiratory tract infection in the first years of life, and it is We included infants between the ages of 15 d and 24 mo
usually a mild to moderate disease. However, some infants hospitalized with a first episode of wheezing diagnosed as
develop severe disease and hospitalization is necessary in
about 1% of previously healthy infected infants [1–3]. Recent
population-based studies have shown that mean annual
hospitalization rates for conditions related to RSV infection
were between 5 and 17 per 1,000 children under 12 mo of age
[4,5].
The treatment of bronchiolitis in infants is largely
supportive, with oxygen supplementation, minimal handling of
the infant, and the use of enteral feeding, intravenous fluids, or
ventilatory support when necessary. Respiratory symptoms
result from bronchiolar obstruction due to inflammatory
edema in the small airways, with an accumulation of mucus
and cellular debris secondary to the epithelial necrosis caused
by the virus [6–8].
Chest physiotherapy is routinely used in children with
chronic respiratory diseases, such as cystic fibrosis and
primary ciliary dyskinesia, or in children with neuromuscular
disease, to facilitate the clearance of tracheobronchial
secretions. Chest physiotherapy aims to clear airway
obstruction, thereby decreasing airway resistance, improving
gas exchange, and making breathing easier. International
recommendations do not recommend chest physio- therapy for
the management of bronchiolitis [9,10]. These
recommendations are based on a recent Cochrane review
analyzing three clinical trials evaluating chest physiotherapy in
infants with bronchiolitis [11]; however, these studies have
several limitations. Most importantly, these studies were based
on percussion and vibration techniques, which are very
different from the increased exhalation technique (IET) with
assisted cough (AC) that might be more appropriate in this
context. IET is designed to clear the distal airways, whereas
AC is known to facilitate large-airway clearance [12,13].
During IET, the manual compression of the infant’s thorax is
aimed at achieving distal airways flow limitation at low lung
volume (as during the rapid thoracic compression lung
function technique [14–16]) to facilitate mucus clearance.
A French consensus panel recommended the use of IET +
AC
in infants with bronchiolitis [17]. Despite the very large use of
IET
+ AC in outpatients with bronchiolitis in France (82.5%–
99%) [18], the efficacy of this technique has so far not been
evaluated. Thus, we conducted a multicenter, randomized,
outcomes assessor-blind and parent-blind trial to evaluate
the efficacy of chest physiotherapy by IET + AC in
previously healthy infants,
hospitalized for a first episode of acute bronchiolitis.

Methods
Ethics Statement
The Saint Germain en Laye ethics committee approved the
study.

Patients
We conducted the study in seven French pediatrics
departments in the Parisian area (Antoine Be´cle`re,
 During the study, a referent physiotherapist at each center
bronchiolitis. Bronchiolitis was diagnosed on the basis of a ensured that chest physiotherapy was consistent and
history of upper respiratory tract infection and clinical standardized.
findings consistent with bronchiolitis, including wheezing or IET involved the generation of synchronized thoracic-
wheezing with crackles and respiratory distress. Infants were abdom- inal movement by the hands of the physiotherapist at
eligible within 24 h of hospitalization if they presented at the beginning of expiration with one hand on the thorax,
least one of the following on meanwhile,
admission: toxic aspect; history of apnea or cyanosis;
respiratory rate .60/min; pulse oxymetry ,95%; alimentary
intake ,2/3 of needs. A maximum of two chest
physiotherapy procedures since admission was allowed
before inclusion.
Infants with severe respiratory distress necessitating
immediately admission to the pediatric intensive care unit
(PICU), with cardiac disease, with a previous significant
respiratory condition, or premature (,34 wk) were not
eligible. Infants were not included
if they had contraindications for the intervention (IET +
AC):
thrombocytopenia, prolonged corticosteroid treatment,
rickets, bone diseases, known rib fracture.
The parents were informed about the study, its aims, and
design. In particular, they were informed that they could not
stay with their children during treatment (to respect blinding).
Both parents gave written informed consent.
Clinical bronchiolitis was confirmed at enrollment and
clinicians determined the duration of symptoms before
hospital- ization, clinical respiratory score, and clinical
variables (respiratory and heart rates, temperature, and
oxygen saturation whilst breathing ambient air). Medical
history was obtained from parents or guardians, on a
standardized data-collection form including questions about
personal history of eczema, family history of asthma or
eczema in parents and siblings, and tobacco smoke in the
home environment.

Randomization
Randomization involved the chest physiotherapist opening
a sealed sequentially numbered envelope containing a random
allocation computer generated with SAS (SAS Inc.) software
packages in advance by the biostatistician. Randomization
was stratified according to center and according to age
(,2 mo, $2 mo) at each center, using permutation blocks
with a block size of four that was not mentioned to the
physicians involved in the patient recruitment.
All pediatric department staff, parents, and guardians were
blind to treatment assignment. Randomization codes were kept
secure until data entry was complete. Thus, those involved in the
evaluation of primary outcome or in the decision of the
cointerventions were blinded to group assignment.

Study Intervention
The treatment, either intervention or control, was
performed by the physiotherapist staying alone with the
infant, in a room with a covered window pane, to ensure that
clinicians and parents could not observe treatment, thus
preserving blinding in the trial. All infants received treatment
three times daily. In each center, four to six physiotherapists,
specially trained to carry out chest physio- therapy in
children, participated in the study. The therapists were not
involved in the evaluation of time to recovery.
Intervention group. The intervention was defined as the
IET followed by AC, with gentle nasal suction (NS).
Just before the start of the study, a senior physiotherapist
presented this technique at each center and all
physiotherapists received formal training in these techniques.
 8 h. Evaluation was based on a clinical score that could be
with the other on the abdomen, centered on the umbilicus, the recorded reliably, every 8 h, by any doctor, nurse, or
physiotherapist applied an abdominal counter-weight. This physiotherapist [20].
maneuver allowed to create a passive expiratory flow. The Secondary outcomes. First, physiotherapists reported side
maneuver began at the end of the inspiratory plateau and was effects during procedures: bradycardia (,80/min)
pursued until the end of expiration, according to the infant’s without
thoraco-pulmonary compliance and up to his or her chest wall
and lung resistance limits. The resulting dynamic compression
of the respiratory system increased expiratory airflow. The
procedure was repeated until meeting auscultation-efficacy
criteria (decrease or disappearance of wheezing and/or
increase of ronchi), but did not last longer than 10 to 15 min.
The procedure was stopped in the case of respiratory status
aggravation. If no spontaneous coughing occurred, coughing
could be triggered by pressure on the suprasternal notch.
Gentle NS with a flexible probe was used to remove mucous
secretions at the end of the procedure. All patients were
closely monitored by continuous pulse oxymetry during chest
physiotherapy.
Control group. Similarly to the intervention group, the
control group also spent 10–15 min in a room alone with
the therapist three times daily. In this group of infants, the
physiotherapists performed only gentle NS to remove mucous
secretions for few minutes and stayed inside the room for the
remaining time without performing any maneuver on the infants.

Other Treatments
All children enrolled in this study followed the same clinical
treatment pathway to ensure consistent care and minimal
variability of the results. Guidelines for the use and
termination of oxygen supplementation and orogastric feeding
or intravenous fluids were followed.
Oxygen supplementation was administered if oxygen
saturation was below 95% when awake and 92% when asleep.
It was stopped when oxygen saturation was consistently above
95% when awake and 92% when asleep. Nurses interrupted
oxygen supplementa- tion three times per day to assess
saturation in room air.
Enteral feeding was administered when possible, with
orogastric feeding offered to infants spontaneously ingesting less
than two- thirds of their daily needs or with significant signs of
chest recession, tachypnea (.60/min) or hypoxemia, or a
worsening of respiratory signs during feeding. Intravenous fluids
were preferred over oral feeding if respiratory conditions did not
improve with orogastric feeding or oral feeding was insufficient
(particularly if vomiting occurred during orogastric feeding). The
use of intravenous fluids stopped when the infant was able to
tolerate
oral feeding. A physician and nurses reevaluated the need for
orogastric feeding and intravenous fluids twice daily.
Other treatments, such as bronchodilators, corticosteroids,
and antibiotics, are not recommended in national and
international guidelines [2,3,10,19], but could be prescribed
freely if physicians felt it appropriate. Data concerning
deviations from the clinical treatment pathway, including drug
treatments, were recorded.

Outcome Measure
Primary outcome. The primary outcome was time from
randomization to recovery. An infant was considered to be
cured if no oxygen supplementation had been given for 8 h and
the child had minimal or no chest recession and was ingesting
more than two-thirds of daily needs. The nursing staff recorded
respiratory and heart rates, oxygen saturation, and signs of
chest recession when the patient was quiet, at least once every
 Meier method, then compared across randomized groups by
desaturation, bradycardia with desaturation using the log-rank test stratified by age group. We additionally
(SpO2,85%), vomiting, transient respiratory adjusted survival analyses for prognostic baseline covariates
destabilization, or bouts of hypotonia requiring the (personal eczema or history of atopy, age in months,
interruption of the procedure. hypoxemia at randomization, need for IV fluids at
Upon discharge from the hospital, parents answered a randomization, atelectasia at randomization, duration of symp-
question- naire regarding their perception of their child’s toms, use of mucolytics before randomization, RSV
comfort and were invited to give their opinion on the efficiency infection),
of physiotherapy for their own child. As parents were not
allowed to be present during the physiotherapy procedure, their
opinion was a global one, based on their observations before
and after each procedure, and on their global evaluation of their
child. Parents answered several questions: (1) During
hospitalization, how would you evaluate the comfort of your
child? Analogical visual scale ranging from 0 (very bad) to 10
(excellent); (2) How would you evaluate how arduous the
physiother- apy procedure was for your child? Analogical visual
scale ranging from 0 (not arduous at all) to 10 (very arduous);
(3) Do you think that the physiotherapy procedure has really
worsened, rather worsened, not changed anything, rather
improved, or really improved the comfort of your child (choose
one answer)?; and (4) Do you think that the physiotherapy
procedure has really worsened, rather worsened, not changed
anything, rather improved, or really improved your child’s
breathing (choose one answer).
Finally, secondary PICU admission and artificial
ventilation, antibiotic treatment were recorded. The parents
were contacted by telephone within 30 d of discharge to
identify cases of relapse and rehospitalization.

Computation of Sample Size

No accurate data for mean time to recovery were available
from the literature. Therefore, to determine the sample size,
we used the duration of hospitalization for bronchiolitis
recorded in the study hospitals during previous years (mean
duration of hospitalization,
6.5 d, and standard deviation [SD], 3.5 d). For a type I error
of
0.05 and a power of 0.80, for detecting a 20% decrease in
time to recovery in the IET + AC group, we needed to include
228 infants (114 infants in each group). One of the aims of
this trial was to investigate possible interactions with age. We
therefore set up two groups of 228 children (under and over
the age of 2 mo), giving 456 children in total. We planned to
include an additional 10% of patients to ensure that we had
sufficient subjects for analysis (due to potential study
dropouts or consent withdrawals). We therefore planned to
enrol 500 infants in this trial.

Statistical Analysis
Analysis was performed on an intent-to-treat basis and all
patients included in the study were analyzed, including the
two lost to follow-up (one in each group).
Baseline demographic data were expressed as number and
percentage for binary or ordinary data, and means 6SD for
continuous data unless skewed, where median and
interquartile range (IQR) were reported. Time failure data
were summarized as medians and 95% confidence interval
(CI) [21].
We first tested treatment by age group (,2 mo and $2
mo) interaction on the primary outcome by fitting Cox models
in each age group, then testing for quantitative interaction with
the Gail and Simon test [22]. No treatment by age interaction
was found (p= 0.97), making it possible to perform the analysis
on the pooled sample. Thus, survival curves for time to
recovery were estimated on the whole cohort using the Kaplan-
using a Cox model. The center effect, that is, difference in skewed variables, 95% CIs were obtained by the bootstrap
baseline risk between centers, was analyzed using frailty models method [24]. All tests were two-tailed, with p-values of 0.05 or
[23]. less considered as statistically significant.
For secondary outcomes, we compared adverse events Statistical analysis was carried out with R version 2.10.11
frequen- cy using the Fisher test. The need for PICU (The R Foundation for Statistical Computing; http://www.R-
admission or ventilation, lung atelectasia, relapse, and the project. org) and SAS version 9.2 (SAS Inc.).
need for antibiotic treatment or secondary hospitalization
were compared between the two groups using the chi square Results
test stratified on age. Data from analogical visual scales were
compared using Wilcoxon test. Finally, we tested treatment by Patients and Baseline Characteristics
covariate interactions on the primary outcome with personal 496 infants were included from October 2004 to January
eczema or history of atopy (history of atopy was defined as 2008 (Figure 1): 246 (49.6%) were assigned to the IET + AC
eczema or asthma in first-degree relatives), hypoxemia group and 250 (50.4%) to the NS group. For153 additional
(SpO2,95%) at randomization, and RSV infection. These infants whose parents were invited to participate, the parents
analyses refused participa- tion. The reasons for their refusal were the
were not prespecified and were identified by post hoc analysis. All desire to stay with their infant, and therefore the impossibility
these quantitative interactions were tested with the Gail and Simon to maintain the blind, and the desire for their children to
test [22]. Measures of treatment effect were either hazard ratio receive IEC + AC treatment.
(HR) for survival data, relative risk (RR) for binary data, mean
differences for continuous data, all given with 95% CIs.
For continuous
Figure 1. Eligibility, randomization, and follow-up of study participants.
doi:10.1371/journal.pmed.1000345.g001
 At randomization, there were no marked differences experienced one episode of bradycardia with desaturation (RR
between the two randomized groups for demographic [95% CI] = 1.0, 0.2–5.0, p= 1.00) or without desaturation
variables, percentage of infants with hypoxemia or feeding (RR = 3.6, 0.7–16.9, p= 0.10). Conversely, the proportion of
difficulties, percentage of infants with nasal aspirate positive children who either had transient respiratory destabilization or
for RSV, and duration of respiratory symptoms before vomited during the procedure was significantly higher in the
hospitalization (Table 1). The proportion of cases of lung group treated with IET + AC than in the group treated with
atelectasia diagnosis on X-ray was higher in the NS group NS (RR
(12.9% versus 7.6%). = 10.2, 1.3–78.8, p= 0.005 and RR = 5.4, 1.6–18.4, p=
Before randomization, 36 (14.4%) infants in the NS group 0.002,
and 47 (19.1%) infants in the IET + AC group received respectively).
bronchodilator inhalations (salbutamol). 34 (13.6%) infants in We obtained 371 (74.8%) responses to parental
the NS group and 25 (10.2%) infants in the IET + AC group questionnaire (187 in the NS group and 184 in the IET + AC
were treated with oral corticosteroids (betamethasone). group). Table 4 summarizes parental answers regarding the
influence of the physiotherapist visit on both the child’s
comfort and respiratory status. According to the parents, the
Primary End Point
procedure was significantly more arduous in the group treated
The physiotherapy intervention (IET + AC) had no
with IET (mean difference [95% CI] = 0.88, 0.33–1.44, p=
significant effect on time to recovery. The median (95% CI) 0.002), whereas there was no significant difference regarding
time to recovery was 2.31 (1.97–2.73) d for the NS group and the comfort of the child between both groups (Difference of
2.02 (1.96–2.34) d for the IET + AC group (HR [95% CI] = mean = 20.07, 20.53 to 0.38, p= 0.40). Finally, there was
1.09, 0.91–1.31, p= 0.33; no significant difference in the way the parents rated the
Figure 2; Table 2). Significant heterogeneity across centers in influence of physiotherapy on respiratory status (RR = 0.99,
baseline hazards was observed (p= 0.001), reflecting a 0.90–1.08, p= 0.89 or comfort (RR = 0.99, 0.94–1.05, p=
difference between centers in time to recovery independently 0.84).
of the treatment effect. After controlling for prognostic 17 (3.4%) infants, including seven (1.4%) requiring
baseline covar- iates, the random effect Cox regression model, ventilatory support, were admitted to the PICU. There was no
that takes into account the center effect, showed that the effect evidence of any difference between groups in the number of
of IET + AC on time to recovery remained not significant (HR infants requiring intensive care admission (RR = 0.7, 0.3–1.8,
= 1.21, 0.97–1.49, p= 0.09). Of note, the center effect p= 0.62) or ventila- tory support (RR = 2.5, 0.5–13.0, p=
persisted, though erased by the handling of baseline prognostic 0.29). 69 (28.5%) infants in the NS group and 67 (28.6%) in
covariate differences (p= 0.03). the IET + AC group received antibiotics (RR = 1.0, 0.7–1.3,
1.00). 53 infants in each group (31.0% in the IET + AC group)
Secondary End Points relapsed within 1 mo after discharge (RR = 1.1, 0.8–1.5, p=
Table 3 summarizes side effects during procedures reported by 0.73). 26 patients were admitted to the hospital within 1 mo
physiotherapists in both groups: there were no significant after discharge (12 in the NS group and 14 in the IET + AC
difference between groups in the proportion of children who group; RR = 1.2, 0.6–2.6, p= 0.68) (Table 5). Respiratory
symptoms were responsible for rehospitalization in 16

Table 1. Demographic characteristics of the infants on admission to the hospital.

Characteristic NS (n= 250) IET + AC (n= 246)

Age (mo), median [IQR] 2.0 [1.3–4.0] 2.1 [1.3–3.8]

Male gender, n (%) 141 (56.4) 134 (54.5)
Gestation (wk), mean ± SD 39.161.65 39.161.67
Environmental tobacco smoke a, n (%) 69 (29.0) 65 (26.9)
Personal eczema or history of atopy a,b, n (%) 100 (40.7) 97 (39.8)
Kindergartena, n (%) 37 (15.0) 29 (12.0)
Bronchodilators before randomization a, n (%) 36 (14.4) 47 (19.1)
Corticosteroids before randomization a, n (%) 34 (13.6) 25 (10.2)
Feeding difficulties before randomization a, n (%) 222 (89.2) 207 (84.8)
Duration of respiratory symptoms at i daysa, media [IQR] 3.0 [2.0–4.0] 3.0 [2.0–4.0]
randomization n n
SpO2,95% at randomization, n (%) 110 (44.2) 106 (44.2)
Atelectasia at randomizationc, n (%) 31 (12.9) 18 (7.6)
Supplementary oxygen and intravenous feeding, n (%)
No oxygen 141 (56.4) 135 (54.9)
Oxygen only 86 (34.4) 86 (34.9)
Oxygen and intravenous feeding 23 (9.2) 25 (10.2)
RSV +, n (%) 152 (76.4) 137 (73.3)
Temperature at randomization (uC), mean ± SD 37.260.7 37.360.6
a
The data were obtained by parental reporting.
b
History of atopy was defined as eczema or asthma in first-degree
relatives. c480 (96.7%) had X-ray at admission.
doi:10.1371/journal.pmed.1000345.t001
 endpoint. In this seven-center trial, no evidence of any difference
in time to recovery between the IET + AC group and the NS
group was found, with no interaction with age group. The CIs
around estimates of effect excluded a clinically meaningful
difference in time to recovery between groups in the whole
population.
Otherwise, there was no evidence of any difference in
secondary outcomes between children with and without IET +
AC except for vomiting and transient respiratory
destabilization during the procedure. This significant
difference of vomiting and respiratory destabilization
frequency was expected and in accordance with our
physiotherapists’experiences. However, it is worth noting that
these side effects of IET + AC were transient and resolved as
soon as the procedure was interrupted. Although not
statistically significant, the percentage of bradycardia during a
procedure was three times higher in the group EIT + AC. This
side effect of IET is rare but known, and it is important to note
that bradycardia quickly disappeared in all children.
For parents, predictably, the perception of the arduousness
of the procedure was significantly higher for IET + AC as
compared to NS. Indeed, IET + AC is a tiring procedure for
children even though the recovery is quick once the procedure
Figure 2. Kaplan-Meier estimates of the proportion of children
is over. This perception may explain the absence of difference
not recovering. between both groups for the evaluation of the global comfort.
doi:10.1371/journal.pmed.1000345.g002 Although we preplanned an economic analysis, it was not
conducted given the negative findings on efficacy outcomes.
Chest physiotherapy is recommended in infants with
(six in the NS group and ten in the IET + AC group) out of 26
bronchi- olitis by the French national consensus guidelines
cases. Gastroenteritis was the other main cause (seven out of [17]. The rationale for such a recommendation is that
26) of secondary hospitalization; the three remaining infants physiotherapy could enhance the clearance of bronchial
were hospitalized for miscellaneous nonrespiratory disorders. secretions, thereby decreasing respiratory distress and chest
recession and increasing oxygena- tion. Airflow has not been
Post Hoc Interaction Test and Subset Analyses assessed in infants undergoing IET, but the feasibility of
No statistically significant quantitative interaction on time to achieving maximal flow (i.e., flow limitation at low lung
recovery between treatment and eczema or atopy history was volumes) has been demonstrated in sleeping healthy infants
found (p= 0.06) (Figure 3; Table 6). HR (95% CI) was equal wearing an inflatable jacket compressing the thorax at the end
to of normal inspiration [16,25] or after lung inflation to total
1.25 (0.99–1.58) for infants without personal eczema or pulmonary capacity [14,15]. When the thorax was compressed
history of atopy and 0.88 (0.66–1.17) for infants with personal from total pulmonary capacity to residual volume, flow
eczema or history of atopy. Similarly, there were no limitation at low lung volumes (distal airways) was achieved
differences in HRs as a function of RSV (HR = 1.01, 0.79– for lower transpulmonary pressure than flow limitation at high
1.28 for infants with and 1.43, 0.94–2.16 for infants without lung volume (large airways) [14,15], but further increase in
RSV infection, p= 0.15), or of hypoxemia at randomization transpulmonary pressure could have a negative effect on flow
(HR = 1.23, 0.96–1.56 for infants without and 0.99, 0.75–1.30 limitation at low lung volumes. These studies conducted in
for infants with hypoxemia at randomization, p= 0.25). healthy sleeping infants do not mimic IET + AC applied in
infants with bronchiolitis. In the present study, pulmonary
Discussion distension could alter chest wall compliance and therefore
transpulmonary pressure transmission. Infants were awake
This study provides an evaluation of chest physiotherapy with the possibility to decreased thoraco- pulmonary
with IET + AC in a large population of infants hospitalized for compliance in response to manipulations, and most of all
a first episode of bronchiolitis with time to recovery as the interindividual variability in IET + AC application could not
primary be avoided despite the optimal training and continuous survey
of IET
+ AC during the study. However, IET + AC is routine practice
in

Table 2. Estimated effect of increased exhalation technique on time to recovery (d) as a function of age (univariate
analyses).

Population NS IET + AC HR [95% CI] of recovery p-Value*

Median time to recovery, d [95% CI]

Overall (n= 496) 2.31 [1.97–2.73] 2.02 [1.96–2.34] 1.09 [0.91–1.31] 0.33
,2 mo (n = 238) 2.64 [2.25–3.08] 2.47 [1.98–3.31] 1.09 [0.84–1.41] 0.51
$2 mo (n= 258) 2.01 [1.65–2.44] 2.00 [1.51–2.25] 1.09 [0.85–1.40] 0.48

*Log-rank test (stratified by age group for overall

analysis). doi:10.1371/journal.pmed.1000345.t002
 Table 3. Side effects reported by physiotherapists during procedures.

Side Effect NS (n= 250) IET + AC (n= 246) Relative Risk [95 CI] p-Valuea
%
Bradycardia with desaturation, n (%) 3 (1.2%) 3 (1.2%) 1.0 [0.2–5.0] 1.00
Bradycardia without desaturation, n (%) 2 (0.8%) 7 (2.8%) 3.6 [0.7–16.9] 0.10
Vomiting during procedure 1 (0.4%) 10 10.2 [1.3– 0.005
(4.1%) 78.8]
Respiratory destabilization 3 (1.2%) 16 5.4 [1.6–18.4] 0.002
(6.5%)
Hypotonia 0 (0.0%) 2 (0.8%) NA 0.24

a
Fischer exact test.
doi:10.1371/journal.pmed.1000345.t003

France and physiotherapists were substantially experienced and not have any clinical relevance. Otherwise, we have previously
trained. Therefore, the study reflects the effectiveness of shown that the clinical signs used for monitoring (respiratory
physiotherapy in infants with bronchiolitis in real life practice as rates and retraction signs) were recorded similarly by all
recommended by guidelines. physicians, nurses, and physiotherapists, with a high level of
Previous studies on chest physiotherapy included smaller interobserver reproducibility [20]. We compared IET + AC
numbers of subjects, with physician-assessed clinical scores as the with NS, because NS provides temporary relief for nasal
primary outcome and nonrelevant variables as secondary congestion and is routinely used.
outcomes (durations of oxygen supplementation and hospitaliza- Age, which was thought to be a possible determinant of IET
tion duration stay) [26–28]. Duration of oxygen supplementation efficacy, did not influence treatment effect. We used a cut-off
was clearly not a relevant outcome because it was required in only point of 2 mo to allow stratifying randomization according to
56.5% of the infants studied. The results of any study including previous recommendations that set the age limit for severe
only infants requiring oxygen supplementation should therefore bronchiolitis between 6 and 8 wk. Indeed, although such a
not be extrapolated to infants not requiring oxygen. dichotomization achieved some loss of information, the
We tried to determine the time to recovery as accurately as effectiveness of chest physiotherapy could have been
possible. It was therefore necessary to assess the conditions of decreased in the youngest owing to their highest risk of severe
the infants around the clock, and not only when physicians disease. Airway size increases with age, and we thought that it
were present. Nurses recorded respiratory signs, heart rate, and would be difficult to increase the clearance of bronchial
SpO2 at least every 8 h, as previously performed [29]. Thus, secretions from very small airways by physiotherapy. The lack
the 0.3-d (which is almost equivalent to 8 h) difference of documented specific mechanisms of pulmonary change
observed between the two randomized groups in median time after IET makes it difficult to draw firm conclusions
to recovery could be related to the study design, which concerning the age-related efficacy of physiotherapy.
hampered the detection of a smaller difference. However, a Post hoc analyses showed no significant quantitative
smaller gain of healing time would interaction between IET + AC effect on the main endpoint
and personal

Table 4. Parental opinions regarding the comfort of their child and the consequences of the procedure on this parameter
and on the respiratory status.

Mean Difference Relative Risk

Parental Opinion NS (n= 187) IET + AC (n= 184) [95% CI] [95% CI] p-Value
Evaluation de the comfort of your child during 7.8 [5.7–9.0] 7.5 [6.2–8.7] 20.07 [20.53 to 0.38] — 0.40a
hospitalization, median (IQR)
Evaluation of the procedure arduous, median (IQR) 4.3 [2.0–6.3] 5.0 [3.0–7.1] 0.88 [0.33–1.44] — 0.002a
Influence of the physiotherapist visit on the — 0.99 [0.90–1.08]b 0.89c
comfort of your baby, n (%)
Worsening 5 (2.7%) 12 (6.5%) — — —
No influence 25 (13.4%) 19 (10.3%) — — —
Improvement 157 (83.9%) 153 (83.2%) — — —
Influence of the physiotherapist visit on the — 0.99 [0.94–1.05]b 0.84c
respiratory status of your baby, n (%)
Worsening 4 (2.1%) 1 (0.5%) — — —
No influence 8 (4.3%) 12 (6.6%) — — —
Improvement 175 (93.6%) 170 (92.9%) — — —

371 couples of parents (74.8%) completed the questionnaire. Percentages were calculated for the population of respondents (n= 371).
a
Wilcoxon test.
b
Relative risk was computed for improvement versus (no influence + worsening).
c
Fischer Exact test.
doi:10.1371/journal.pmed.1000345.t004
 Table 5. Secondary outcomes.

Secondary Outcome NS (n= 250) IET + AC (n= 246) Relative Risk [95 CI] p-Value a

%
PICU admission, n (%) 10 (4.1%) 7 (2.9%) 0.7 [0.3–1.8] 0.62
Ventilation, n (%) 2 (0.8%) 5 (2.0%) 2.5 [0.5–13.0] 0.29
Antibiotics 69 (28.5%) 67 (28.6%) 1.0 [0.7–1.3] 1.0
Relapse 53/182 (29.1%) 53/171 (31.0%) 1.1 [0.8–1.5] 0.73
New hospitalization 12/182 (6.6%) 14/171 (8.2%) 1.2 [0.6–2.6] 0.68

Data obtained from the parents by telephone interview 30 d after discharge. We obtained 353 responses (71.2%) and percentages were calculated for the
population of respondents (n= 353).
a
Fischer exact test for percentage comparison.
doi:10.1371/journal.pmed.1000345.t005

atopy or history of atopy in first-degree relatives, the type of even though family history of atopy and atopic dermatitis in
virus, or the presence of baseline hypoxemia. Although the infant have been shown to be predictive of asthma [31]. It
exploratory, our findings for infants without personal atopy or is possible that future studies will lead to recommendations for
history of atopy in first-degree relatives and for those without bronchiolitis treatment according to the phenotype of the
hypoxemia were close to statistical significance as shown by the infant, rather than merely being based on current disease
CIs around estimate of effect for these subgroups (respectively diagnosis alone [32]. Our study was not designed to address
[0.99–1.58] and [0.96– 1.56]) and deserve further investigations. this issue and atopic status was not found to influence the
Infants included in the present study represent a spectrum of effect of IET + AC.
bronchiolitis phenotype including infants prone or not prone to The physiopathology of bronchiolitis remains unclear, but
experience repeated wheezing episodes. Reynolds et al. [30] the need for oxygen supplementation is considered as a marker
suggested that there might be two different groups of patients: of considerable ventilation heterogeneity, due to a large
those with obstructive disease resulting entirely from infection, number of units with poor ventilation (obstructed) and good
thickening of the bronchiolar walls, and intrabronchial secretions, perfusion or overdistension and poor perfusion. In the absence
and those with a predisposition to asthma, who develop of segmental or lobar lung atelectasia, ventilation heterogeneity
obstruction because of both inflammation and bronchospasm. It is a peripheral phenomenon unlikely to be affected by
is still currently impossible to determine which of the infants physiotherapy. Infants requiring oxygen supplementation may
hospitalized for bronchiolitis will subsequently develop asthma, not benefit at all from physiotherapy, but the benefits of
physiotherapy for nonhypoxe- mic infants did not reach
significance (Figure 3; Table 5). Studying a mixture of patients
may provide unclear or misleading results. This perspective
raises questions about limiting studies to homogeneous
populations, making it impossible to extrapolate the results
obtained to patients with a different clinical status. The
heterogeneity in concerned patient populations may contribute
to the difficulty of definitively evaluating physiotherapy in
clinical trials and in making clear recommendations on its
benefit in practice.
The ‘‘interphysiotherapist’’ variability is an important issue
in our study. Despite having taken great care in optimizing the
training, some variability in the way compression was applied
may remain and is difficult to evaluate. We deliberately chose
to have more than one physiotherapist by center to mimic as
closely as possible real-life conditions, and to be able to
extrapolate our results, should they have been positive. The
problem of practitioner variability for complex interventions is
common in nonpharmacological trials. We standardized the
cessation of the intervention on the same auscultation-efficacy
criteria in order to reduce interphysiotherapist variability.
In summary, this large, randomized, controlled, outcomes
assessor-blind and parent-blind trial of three daily chest
physio- therapy sessions with the IET technique in infants
hospitalized for a first episode of bronchiolitis provided no
Figure 3. HRs and 95% CIs for healing in the group receiving evidence that this treatment shortened time to recovery. Our
IET + AC, as compared with the NS group, as a function of results did not support the recommendation that chest
baseline prognostic factors. History of atopy was defined as the physiotherapy be routinely performed in hospitalized infants
presence of eczema or asthma in first-degree relatives. with acute bronchiolitis. Our conclusions in infants with severe
doi:10.1371/journal.pmed.1000345.g003
bronchiolitis cannot necessarily be extrapolated to infants with
mild or moderate bronchiolitis. Further studies would be
required to assess chest physiotherapy in outpatients and for
infants without history of atopy.
 Table 6. Search for treatment by covariate interactions on the main outcome measure, time to recovery.

Prognostic Baseline Covariate NS IET + AC HR [95% CI] of Recovery p-Valuea

Median Time to Recovery, d [95% CI]

b,c
Personal eczema or history of atopy 0.06
Yes (n = 197) 1.96 [1.36–2.73] 2.30 [1.73–3.07] 0.88 [0.66–1.17]
No (n= 293) 2.42 [2.04–2.85] 2.02 [1.92–2.33] 1.25 [0.99–1.58]
RSVd 0.15
Positive (n= 289) 2.34 [1.97–2.99] 2.33 [1.94–2.88] 1.01 [0.79–1.28]
Negative (n= 97) 2.33 [1.35–3.32] 1.92 [1.29–2.08] 1.43 [0.94–2.16]
Hypoxemia at randomization 0.25
Yes (n= 216) 2.73 [2.30–3.32] 2.47 [2.02–3.17] 0.99 [0.75–1.30]
No (n= 273) 1.90 [1.36–2.52] 1.96 [1.51–2.08] 1.23 [0.96–1.56]
a
p-Value refers to the statistics of Gail and Simon’s quantitative interaction test (1df-chi-squared test).
b
The data were obtained from the parents.
c
History of atopy was defined as eczema or asthma in first-degree relatives.
d
RSV was tested in only 386 infants.
doi:10.1371/journal.pmed.1000345.t006

Supporting Information Enfants Malades, Universite´ Paris 5, Rene´ Descartes), and P. Hubert
(Pediatric Intensive Care Unit, Necker, Enfants Malades, Universite´
Alternative Language Text S1 French translation of the article by
Paris 5, Rene´ Descartes). We thank C. Perez, clinician psychologist,
VG. for her help for parental perception recording. We thank the project
Found at: doi:10.1371/journal.pmed.1000345.s001 (0.34 MB manager, M. Legrand (APHP, Research Direction), and the research
PDF) assistants A. Doutres, and A. Traore´. We thank all local physicians,
Text S1 Trial protocol. physiotherapists, the nursing staff, all patients, and their parents who
Found at: doi:10.1371/journal.pmed.1000345.s002 (0.30 MB participated in this study. None of those listed received any financial
compensation for their contributions.
PDF)
Text S2 CONSORT checklist. Author Contributions
Found at: doi:10.1371/journal.pmed.1000345.s003 (0.11 MB
PDF) ICMJE criteria for authorship read and met: VG SK NB VA LdP SL
RE BC SB AMB JB SC PL. Agree with the manuscript’s results and
conclusions: VG SK NB VA LdP SL RE BC SB AMB JB SC PL.
Acknowledgments Designed the experiments/the study: VG NB VA RE SB SC PL.
We thank our Independent Safety Monitoring Board, namely, P. Blanc Analyzed the data: VG SK VA. Collected data/did experiments for the
(Pediatric Department, Poissy, Saint Germain Hospital), L. Chevret study: VG NB VA AMB. Enrolled patients: VG NB VA LdP SL RE
(Pediatric Intensive Care Unit, Kremlin Biceˆtre Hospital, Universite´ BC. Wrote the first draft of the paper: VG NB VA. Contributed to the
Paris Sud 11), C. Delacourt (Pediatric Pulmonology Department, writing of the paper: VG SK NB VA LdP SL RE BC SB AMB JB SC
Necker, PL. Supervised the intervention of physiotherapists: SB.

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Editors’ Summary
Background. Bronchiolitis, which is usually caused by the working alone in a room with blacked-out windows. The
respiratory syncytial virus (RSV), is the commonest infection primary outcome of the trial was the patients’ time to
of the lower respiratory tract (the lungs and the passages recovery. Infants were judged to have recovered if they
through which air enters the lungs) in infants. A third of all had not had oxygen therapy or showed signs of chest
children have bronchiolitis during their first year of life. recession for 8 hours and had ingested more than two-
The illness begins with stuffiness, a runny nose, a mild thirds of their daily food requirement. Infants in the control
cough, and mild fever. Then, as the smallest airways in group took an average of 2.31 days to recover whereas
the lung (the bronchioles) become inflamed (swell) and those in the intervention group took 2.02 days. However,
blocked with mucus, the cough worsens, and the infant this difference in recovery time was not statistically
may develop a wheeze, shallow breathing, and a rapid significant. That is, it could have happened by chance.
heartbeat. Most cases of bronchiolitis are mild and clear The researchers also recorded several secondary
up within two weeks without any treatment but some outcomes such as admission to an intensive care unit,
infants develop severe disease. Such infants struggle to help with breathing, antibiotic treatment, and parental
get enough air into their lungs, drawing in their chest with perceptions of their child’s comfort. There were no
each breath (chest recession). They have trouble eating significant differences between the two treatment groups
and drinking, and the oxygen level in their blood can drop for any of these secondary outcomes, although the
dangerously low. About 1% of previously healthy infants parents did report that the IET + AC treatment was
need hospitalization because of severe bronchiolitis. harder on their children than nasal suction while not
These severely affected infants are not normally given reducing their overall comfort.
any medications but, where necessary, they are given
oxygen therapy, fed through a tube into their stomach, What Do These Findings Mean? These findings show
and given fluids through a vein. that IET + AC had no significant effect on the time to
recovery of a large population of French infants admitted
Why Was This Study Done? In some countries, chest to hospital with severe bronchiolitis. These results cannot
physiotherapy is routinely given to infants with be extrapolated, however, to infants with mild or
bronchiolitis even though this is not a recommended moderate bronchiolitis, and further studies are needed to
treatment inter- nationally. In France, for example, assess whether chest physiotherapy is of any benefit in
virtually all outpatients with bronchiolitis receive a form of an outpatient setting. Three small trials of a different form
chest physiotherapy known as increased exhalation of chest physiotherapy have also previously failed to find
technique with assisted cough (IET + AC). IET—manual any effect of chest physiotherapy on recovery time. Thus,
chest compression—is de- signed to clear mucus from none of the currently available results support the routine
the bronchioles whereas AC— coughing triggered by use of chest physiotherapy in infants admitted to a
applying pressure to the top of the breastbone—facilitates hospital for severe bronchiolitis.
clearance of the large airways. But is IET + AC an effective
treatment for bronchiolitis? In this study, the researchers Additional Information. Please access these Web sites
undertook a multicenter, randomized, controlled trial to via the online version of this summary at
answer this question. A randomized trial is a study in http://dx.doi.org/10. 1371/journal.pmed.1000345
which patients are randomly allocated to receive either
the treatment under study or a control treatment. Usually
in such trials, noone is aware of the treatment allocations
N provides
The UK National Health Service Choices Web site
detailed information on all aspects of
until the trial has been completed. This is called blinding bronchiolitis
and avoids unconscious biases being introduced into the
results. In this trial, although the parents, caregivers, and N Foundation
Kidshealth, a resource maintained by the Nemours
(a not-for-profit organization for children’s
outcome assessors were blinded, the physiotherapists health) provides information for parents on bronchiolitis
and the infants were aware of treatment allocations. The schizophrenia and on respiratory syncytial virus (in
physiotherapists were not involved in patient English and Spanish)
assessment, however, and the infants were sufficiently
young that their knowledge of their treatment was unlikely N on
The British Lung Foundation also provides information
bronchiolitis schizophrenia and on respiratory
to bias the results. syncytial
virus
What Did the Researchers Do and Find? The
researchers enrolled nearly 500 children aged 15 days to
2 years who were admitted to seven French hospitals for
N bronchiolitis
The MedlinePlus encyclopedia has a page on
schizophrenia (in English and Spanish)
a first episode of acute bronchiolitis. They randomly
allocated the patients to receive IET + AC (intervention N detailed
The US Centers for Disease Control and Prevention has
information on respiratory syncytial virus
group) or nasal suction (control group) three times a day
from a physiotherapist