Journal of Critical Care 67 (2022) 95–99

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Journal of Critical Care

journal homepage: www.journals.elsevier.com/journal-of-critical-care

1-hour t-piece spontaneous breathing trial vs 1-hour zero pressure

support spontaneous breathing trial and reintubation at day 7:
A non-inferiority approach
Arnaud Gacouin a,b,c,⁎, Mathieu Lesouhaitier a,b, Florian Reizine a,b, Benoit Painvin a,b, Adel Maamar a,b,
Christophe Camus a,b, Yves Le Tulzo a,b,c, Jean Marc Tadié a,b,c
a
CHU Rennes, Maladies Infectieuses et Réanimation Médicale, F-35033 Rennes, France
b
Université Rennes1, Faculté de Médecine, Biosit, F-35043 Rennes, France
c
Inserm-CIC-1414, Faculté de Médecine, Université Rennes I, IFR 140, F-35033 Rennes, France

a r t i c l e i n f o a b s t r a c t

Available online xxxx Purpose: Physiological data suggest that T-piece and zero pressure support (PS0) ventilation both accurately re-
flect spontaneous breathing conditions after extubation. These two types of spontaneous breathing trials (SBTs)
Keywords: are used in our Intensive Care Unit to evaluate patients for extubation readiness and success but have rarely been
Extubation outcome compared in clinical studies.
Spontaneous breathing trial Materials and methods: We performed a prospective observational study to confirm the hypothesis that 1-hour
Mechanical ventilation T-piece SBT and 1-h PS0 zero PEEP (ZEEP) SBT are associated with similar rates of reintubation at day 7 after
Pressure support ventilation
extubation. A non-inferiority approach was used for sample size calculation.
Ventilator weaning
Cohort study
Results: The cohort consisted of 529 subjects invasively ventilated for more than 24 h and extubated after success-
ful 1-hour T-piece SBT (n = 303, 57%) or 1-h PS0 ZEEP SBT (n = 226, 43%). The reintubation rate at day 7 was
14.6% with PS0 ZEEP and 17.5% with T-piece (difference − 2.6% [95% confidence interval, −8.3% to 4.3%]; p =
0.40). The reasons for reintubation did not differ significantly when compared between patients with 1-h PS0
ZEEP SBT and patients with 1-hour T-piece SBT.
Conclusion: Our results suggest that successful 1-hour T-piece and 1-h PSO ZEEP SBTs are associated with similar
reintubation rates at day 7.
© 2021 Published by Elsevier Inc.

1. Introduction SBT, the subject is disconnected from the ventilator, and additional ox-
ygen is provided without positive pressure. The PS SBT is generally con-
Avoiding unnecessary extension of mechanical ventilation (MV) du- ducted with a low level of PS and performed without disconnecting the
rations without exposing patients to an increased risk of extubation fail- patient from the ventilator. Low levels of PS are typically applied during
ure is a daily concern in the intensive care unit (ICU). In practice, MV the PS SBT to compensate for the imposed workload due to the ventila-
weaning parameters are first assessed by clinicians, and then the tor circuit. So far, the standard is a SBT with 8 cmH2O PS ventilation with
weaning test is decided [1]. In subjects invasively ventilated for more our without PEEP. However, the work imposed by the ventilator circuit
than 24–48 h, it is recommended to test their ability to breathe with has been considerably reduced with technological improvements [7].
no assistance or with a minimal level of assistance before extubation The aim of using a 1-h PS0 ZEEP SBT more than a 1-hour T-piece SBT
[2,3]. A standard test for extubation readiness is the spontaneous is not to hasten extubation but to take potential advantages associated
breathing trial (SBT). The SBT can be more or less effort demanding de- with maintaining the connection between the patient and ventilator.
pending on its duration (typically between 30 min and 2 h [4,5]) and First, adequate humidification is ensured throughout SBT, and alarms
whether it is conducted without (i.e., T-piece SBT) or with low levels for expiratory volume and respiratory breath are activated. Second,
of pressure support (PS) ventilation (i.e., PS SBT) [6]. In the T-piece expiratory volume can be monitored, allowing calculation of minute
ventilation and ratio of respiratory breath on expiratory volume, and
these features are not available with the T-piece procedure. Third, the
mode of ventilation used prior to extubation can be easily and quickly
⁎ Corresponding author at: Service des Maladies Infectieuses et Réanimation Médicale,
CHU Rennes, F-35033 Rennes, France.
reintroduced in patients who fail SBTs, especially in those with severe
E-mail address: [email protected] (A. Gacouin). signs of respiratory or haemodynamic poor tolerance. Fourth, there is

https://doi.org/10.1016/j.jcrc.2021.10.016
0883-9441/© 2021 Published by Elsevier Inc.
A. Gacouin, M. Lesouhaitier, F. Reizine et al. Journal of Critical Care 67 (2022) 95–99

less handling of the ventilator tubing and less risk of aerosols when flow oxygen therapy (HFOT), time and reason for reintubation, length
disconnecting, especially in patients with pulmonary infection. Follow- of ICU stay, and ICU and hospital mortality. Extubation failure was de-
ing a physiologic meta-analysis, Michael C Sklar et al. [8] concluded that fined as a need for reintubation within the 7 days following extubation.
T-piece SBT and PS of 0 cm H2O (PS0) SBT both accurately reflect phys- The main reasons for intubation, risk factors for extubation failure, un-
iologic conditions of extubation. One-hour T-piece SBT or 1-h PS0 with derlying chronic respiratory diseases, underlying cardiac diseases, obe-
zero end expiratory pressure (ZEEP) SBT are both used in our ICU to sity, weaning groups, the amount of secretions scoring and quality of
test subjects before extubation depending on the physician in charge cough, and reason for reintubation are defined in the supplemental ma-
of the subject. Despite published recommendations, MV weaning prac- terial. All subjects in the study were assessed for the first extubation
tices vary between teams [9], and we suspect that maintaining the pa- during the ICU stay.
tient connected to the ventilator with a low trigger and PS0 ZEEP
during SBT could be a widespread practice that, to the best of our 2.3. Sample size calculation and statistical analysis
knowledge, has not been previously assessed in a large population. To
evaluate our practices and to confirm the hypothesis that extubation To avoid a lack of power, we used a non-inferior approach for the
failure rates are similar whether extubation is performed following T- sample size calculation. First, and although we did not perform a ran-
piece or PS0 ZEEP SBT, we performed a prospective observational study. domized controlled study, the minimum number of subjects needed
in each group was calculated based on the hypothesis that 1-h PS0
2. Patients and methods ZEEP SBP was non-inferior to 1-hour T-piece SBP for extubation failure
at day 7. In a prospective randomized study, a minimum of 219 subjects
2.1. Patients per group should have been included to provide a power of 90% rather
than 80% to establish non-inferiority to T-piece SBT using a 15%
The study was approved by the hospital's ethics committee (number reintubation rate at day 7, a 10% non-inferiority margin, and a 2-sided
18–24). Subjects intubated for more than 24 h, without do not α level of 0.05 [20]. Data are expressed as numbers and percentages
reintubate order and tested for extubation with SBT were screened for and as medians and interquartile ranges (IQRs). The chi-square test
the study. In our 24-bed ICU of a tertiary teaching hospital, the duration was used to compare categorical variables, and the Mann-Whitney
of the SBT is planned for 1 h in all subjects and stopped earlier when U test was used to compare continuous variables. Second, we expressed
poorly tolerated. Two ventilators were available during the study differences in clinical outcomes (SBT and reasons for reintubation)
period: Evita XL (Dräger) and Servo I (Getinge). The 1-hour T-piece or using the absolute difference with 95% confidence intervals (Cis).
1-h PS0 ZEEP SBT was decided by the physician in charge. During SBT, Third, Kaplan-Meier curves were constructed for freedom from
respiratory and heart rates, pulse oximetry (SpO2), arterial blood reintubation at day 7 and compared by log rank test. Deaths occurring
pressure, and transcutaneous PCO2 (PtcCO2) (TCM5, Radiometer, before day 7 were introduced in the survival analysis as censored data.
Copenhagen, Denmark) were monitored and recorded at 0, 15, 30, 45, In addition, a multiple logistic regression analysis was performed for
and 60 min after the start of the SBT. Subjects were also monitored for extubation failure or success at day 7 to adjust on 1-hour T-piece SBT
signs of poor respiratory and haemodynamic tolerance. In accordance and on variables achieving a p-value <0.05 in the unadjusted analysis
with previous studies, the following criteria are used in our ICU to define after comparison between patients who failed and patients who
SBT failure: development during the SBT of any of the following events succeeded extubation at day 7. The results are presented as odds ratios
including respiratory rate > 35 breaths/min, increased accessory (ORs) with 95% Cis with continuity correction. Repeated measures were
muscle activity, SpO2 persistently less than 90% despite increasing compared with the use of two-way analysis of variance (ANOVA).A
FiO2, heart rate persistently greater than 140 beats/min, systolic blood two-tailed p < 0.05 was considered to indicate statistical significance.
pressure < 90 or > 180 mmHg, appearance of cyanosis or mottling, Statistical analyses were performed using the Statistical Package for So-
depressed mental status or agitation [2,3,10,11]. cial Sciences 25 (SPSS, IBM., Chicago, IL, USA).
Extubations were performed with the assistance of a nurse and a
physiotherapist under the physician's control. Patients were identified 3. Results
ready to undergo an SBT and to have failed SBT using criteria from the
international conference consensus on weaning [10]. 3.1. Patients

2.2. Data collection From February 1, 2018 to December 12, 2020, 895 patients received
more than 24 h of MV, among whom 623 patients (69%) were screened
In addition to the variables monitored during SBT, based on recent for the study because they performed at least one SBT. Of note, 38 sub-
literature [2,3,11-14], the following data were prospectively recorded: jects (6%) were excluded from the study because they had PS8 ZEEP SBT
baseline characteristics of subjects at admission, including simplified after inclusion in the Tip-Ex study [21]. Five hundred and twenty-nine
acute physiology score (SAPS) II [15], moderate to severe acute respira- subjects with no missing data were observed, and their data were
tory distress syndrome (ARDS) [16], risk factors for extubation failure analysed. Among the 529 subjects, 303 subjects (57%) underwent
[3,12,17], the main reason for intubation, and weaning difficulty. Sub- 1-hour T-piece SBT, and 226 subjects (43%) underwent 1-h PS0 ZEEP
jects were distinguished by whether they were extubated within 24 h SBT before being extubated (Fig. 1). The characteristics of subjects be-
after the first SBT (defined as simple weaning), extubated more than fore extubation, day of extubation, and NIV received after extubation
24 h and less than 7 days after the first unsuccessful SBT (defined as were compared to determine whether subjects underwent 1-hour
difficult weaning), and extubated more than 7 days after the first unsuc- T-piece SBT or 1-h PS0 ZEEP SBT before extubation, and the results
cessful SBT (defined as prolonged weaning) [10]. Subjects were classi- are listed in Table 1. Among the 83 postoperative subjects, 50 pa-
fied for weaning difficulty independently of the issue of extubation tients (60%) were liver transplant recipients, and 13 patients (16%)
and based exclusively on the fact that the patient was extubated or underwent cardiac surgery. Subject characteristics did not differ be-
not. At the time of extubation, the following data were recorded: body tween the two groups of subjects (Table 1).
mass index, sequential organ failure assessment (SOFA) scores [18],
previous duration of MV, number of previous SBTs without extubation, 3.2. Primary outcome
ventilator settings, quality of cough strength and amount of secretions
assessed by nurses [19]. Variables recorded after extubation included The reintubation rate at day 7 after extubation was 17.5% (95% CI,
the following: treatment with noninvasive ventilation (NIV) and high- 13.2%–21.8%) with a 1-hour T-piece SBT and 14.6% (95% CI, 10.0%–

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A. Gacouin, M. Lesouhaitier, F. Reizine et al. Journal of Critical Care 67 (2022) 95–99

Table 1
Baseline characteristics of the patients.

Variable 1-hour T-piece 1-h PS0 P

SBP ZEEP SBP value

n = 303 n = 226

Age, median (IQR), years 62 (54–70) 60 (53–68) 0.22

Sex, n (%) 0.39
Men 212 (69.9) 150 (66.3)
Women 91 (30.1) 76 (33.7)
SAPS II score at admission, median 51 (36–64) 47 (37–58) 0.22
(IQR)
Respirator, n (%) 0.52
Evita XL Dragger 182 (60.1) 142 (62.8)
Servo I Maquet 121 (39.9) 84 (37.2)
Size of endotracheal tube 0.16
7 105 (34.7) 93 (41.1)
7.5 155 (51.1) 97 (42.9)
Other than 7 or 7.5 43 (14.2) 36 (15.9
Main reason for intubation, n (%) 0.26
Surgery 46 (15.2) 37 (16.4)
Acute respiratory failure 102 (33.6) 96 (42.4)
Acute on chronic respiratory failure 32 (10.6) 20 (8.3)
Cardiac arrest 16 (5.3) 9 (3.5)
Shock 33 (10.9) 25 (11.1)
Fig. 1. Flow chart of subjects. Central nervous system disorder 62 (20.5) 37 (16.3)
Other 12 (3.9) 2 (2.0)
Obesity, n (%) 101 (32.7) 61 (26.1) 0.12
ARDS, n (%) 47 (15.5) 49 (21.6) 0.068
19.2%) with a 1-h PS0 ZEEP SBT (difference, −2.6%; 95% CI, −8.3% to Weaning difficulty 0.16
4.3%, p = 0.40) (Table 2). After adjustment on ventilator settings before Simple 180 (59.4) 131 (57.9)
SBT and absent or weak cough, the OR of 1-hour T-piece SBT for Difficult 89 (29.4) 79 (34.9)
Prolonged 34 (11.2) 16 (7.2)
reintubation at day 7 was 1.02 (95% CI, 0.24–4.29, p = 0.97). The
Risk factor of extubation failure, n (%)
Kaplan-Meier curve constructed from time to extubation until day 7 Age > 65 years 115 (37.9) 75 (33.1) 0.26
after extubation showed no significant difference in freedom from MV duration >7 days, n (%) 164 (54.1) 113 (50.0) 0.35
reintubation between the two SBT methods (Fig. 2). Underlying chronic cardiac disease, 97 (32.0) 78 (34.5) 0.55
n (%)
Underlying chronic respiratory 109 (35.9) 79 (34.9) 0.81
3.3. Secondary outcomes disease, n (%)
Previous neurological disorder, n (%) 69 (22.7) 45 (19.9) 0.42
Duration of MV before extubation, 8 (5–14) 7 (4–15) 0.68
We found no significant difference when the two methods of SBT
median (IQR), days
were compared for reintubation rates at 48 h, reintubation or death BMI the day of extubation, median 26 (23−31) 26 (22–29) 0.065
rates at day 7, number of SBT attempts before extubation, and delays (IQR), kg/m2
between first SBT and extubation (Table 2). SOFA score the day of extubation, 4 (2–5) 4(2–5) 0.97
median (IQR), point
Ventilator settings before SBT 0.03
3.4. Exploratory outcomes PS ventilation 215 (70.9) 140 (61.9)
Assist-control ventilation 88 (29.0) 86 (38.0)
Length of stay in the ICU, ICU and hospital mortality rates did not dif- PaO2/FiO2 before SBT, median (IQR) 283 (220–362) 280 (228–342) 0.43
mmHg
fer significantly whether subjects were extubated after 1-hour T-piece
PaCO2 before SBT, median (IQR) mmHg 39 (34–43) 39 (35–46) 0.18
SBT or 1-h PSO ZEEP SBT (Table 2). In addition, reasons for reintubation Absent or weak cough, n (%) 94 (34) 51 (22) 0.039
did not differ between the two different types of SBTs (Table 3). Abundant or very abundant secretions, 104 (35) 87 (41) 0.38
Repeated values of heart rate, systolic arterial pressure, and PtcCO2 n (%)
Reconnection to ventilator and at-least 147 (48.5) 120 (53.1) 0.30
did not differ significantly whether SBT was performed with a T-piece
1-h of PS
or PS0 ZEEP (Supplemental Fig. 1). Respiratory rate and SpO2 values or assist-control ventilation before
were significantly increased in subjects patients with PS0 ZEEP com- extubation
pared with subjects with a T-Piece with a mean difference of 1.8 breaths Non invasive ventilation after 0.83
rate per minute and of 2% respectively (p < 0.001). extubation
None 177 (58.4) 137 (60.6)
Prophylactic immediately after 107 (35.3) 77 (34.1)
3.5. Additional and subgroup analyses extubation
Not prophylactic to treat respiratory 19 (6.3) 12 (5.3)
worsening
Among the 267 subjects who were reconnected and ventilated at
Prophylactic high-flow nasal canula 22 (7.2) 21 (9.3) 0.54
least one hour before extubation, the rate of reintubation at day 7 did after extubation
not differ significantly between subjects with a 1-hour T-piece SBT (29
SBT, spontaneous breathing trial; PS, pressure support; PEEP, positive end expiratory pres-
of 147 subjects, 20%) and patients with a 1-h PS0 ZEEP (22 of 120 sure; IQR, interquartile range; ARDS, acute respiratory distress syndrome; MV, mechanical
subjects, 18%) (p = 0.77 after comparison). Similarly, the rates of ventilation; BMI, body mass index; SOFA, sepsis failure organ assessment.
reintubation at day 7 did not differ significantly between 1-hour
T-piece subjects and 1-h PS0 ZEEP subjects in the subgroup of subjects
who received prophylactic NIV (19% vs 17%, respectively, p = 0.75). In T-piece SBT (19%) and 1-h PS0 ZEEP (16%) (p = 0.43). Survival-free
addition, when a comparison was performed on the subgroup of 266 days of reintubation from the date of the first SBT to day 7 after
subjects who were ventilated for more than 48 h, reintubation rates at extubation did not significantly differ between the two types of SBTs
day 7 after extubation did not significantly differ between the 1-hour (p = 0.22 by the log-rank test).

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A. Gacouin, M. Lesouhaitier, F. Reizine et al. Journal of Critical Care 67 (2022) 95–99

Table 2
Primary, secondary, and exploratory outcomes.

Primary, secondary and exploratory outcomes 1-h PS = 0 PEEP = 0 SBP 1-hour T-piece SBP Absolute Difference, (95% CI) P value

n = 226 n = 303

Primary outcome
Reintubation at day 7, n (%) 33 (14.6) 53 (17.5) −2.6 (−8.3 to 4.3) 0.40
Secondary outcomes
Reintubation at 48 h, n (%) 22 (9.7) 42 (13.8) −4.5 (−9.6 to 1.6) 0.15
Reintubation or death at day 7, n (%) 35 (15.4) 56 (18.4) −3.6 (− 9.4 to 3.4) 0.43
Extubation after the first SBT, n (%) 146 (64.6) 207 (68.3) −3.8 (− 1.1 to 5.1) 0.48
Delay between the first attempt of SBP and extubation, median (IQR), hours 0 (0–24) 0 (0–24) −7.5 (− 24.7 to 23.6) 0.49
Exploratory outcomes
Length of stay in the ICU, median (IQR) 11 (6–21) 10 (6–20) 0.4 (− 2.1 to 2.9) 0.82
Mortality in ICU, n (%) 14 (6.2) 21 (6.9) −0.008 (− 0.05 to 0.03) 0.71
Mortality in hospital, n (%) 33 (14.6) 48 (15.8) −1.6 (− 7.5 to 5.2) 0.71

after extubation was lower than that in the study of C. Subirà et al.
[12] and than that in the study of AW. Thille et al. [11]. Less than 10%
of the patients received HFNOT because this therapy was not recom-
mended as a systematic treatment in patients at highest risk of
reintubation during the study period. In addition, HFNOT was not avail-
able with Servo I ventilators.
As we reported, all subjects with risk factors for reintubation did not
receive prophylactic NIV. Prophylactic NIV was first used mainly in pa-
tients with chronic obstructive pulmonary disease and second extended
to patients with underlying chronic cardiac disease according to the
HIGH-WEAN study [21]. Moreover, prophylactic NIV was not systemat-
ically applied in patients older than 65 years without respiratory or car-
Fig. 2. Probability of freedom from reintubation after the first spontaneous breathing trial
diac diseases but left at the discretion of physician in charge. Along these
in each group. lines, the systematic 1-h reconnection period with prior ventilator set-
tings after a successful SBT and before extubation was implemented
during the study period when data from Fernandez et al. were pub-
lished [24]. Although these two studies induced significant changes in
4. Discussion our weaning practices, we did not find a significant difference in the fre-
quency of reintubation regardless of whether the subjects received NIV
As hypothesized, we found that reintubation rates at day 7 did not after extubation or were reconnected after successful SBT.
differ significantly whether subjects were extubated after successful The authors reported that in morbidly obese patients, a T-piece trial
1-hour T-piece SBT or successful 1-h PS0 ZEEP SBT. In addition, and the test performed without disconnecting the subjects with no PS
reintubation rates at 48 h, reintubation or death rates at day 7, and pro- ventilation and no PEEP predicted post-extubation work of breathing
portions of patients extubated after the first attempt of SBT did not differ better than tests realized with PS ventilation and/or PEEP with similar
significantly after comparison between the 1-hour T-piece SBT and 1-h accuracy [25]. In a physiologic meta-analysis assessing and comparing
PS0 ZEEP. respiratory effort during T-piece SBT with various modalities of PS ven-
For the whole population, the rate of reintubation at day 7 was tilation, the authors concluded the equivalence of T-piece and PS0 trials
16.2%, which is in the range of the 10 to 20% rate generally reported in [8]. Indeed, the “physiological” rationale existed to consider that evalu-
studies [11,12,17,22,23]. In addition, this rate was very close to the ation of extubation readiness and success by 1-hour T-piece SBT and 1-h
15% used for the sample size calculation. The baseline characteristics PS0 ZEEP SBT could provide similar results. However, to our knowledge,
of subjects were similar to those reported in recent [11-13] and older this comparison has not been previously realized during a clinical study.
[4] studies focusing on weaning from MV and the periextubation period. The results of repeated respiratory and cardiac parameters recorded and
Similar to that reported in previous recent studies [11,12], a high per- compared between the two types of SBTs suggest that one is not more
centage of our patients had a successful initial SBT followed by success- effort-demanding than the other.
ful extubation at day 7. On the other hand, the proportion of subjects Our study has several limitations. First, it was conducted at a single
who received prophylactic high-flow nasal oxygen therapy (HFNOT) site; thus, the results may not be applicable to other ICUs. Second, the

Table 3
Reasons for reintubation.

Reason for reintubation, n (%) 1-hour T-piece SBP 1-h PS = 0 PEEP = 0 SBP Absolute Difference, (95% CI) P value

n = 50 n = 33

Excessive work of breathing 12 (24.0) 12 (36.3) −12.3 (−31.9 to 7.2) 0.27

Difficulty in managing secretions 10 (20) 4 (12) 7.9 (−11.6–24.2) 0.17
Refractory hypoxemia 9 (18.0) 3 (9.0) 8.9 (− 9.7 to 24.3) 0.12
Level of consciousness 5 (10) 2 (6.1) 3.9 (−12.8 to 17.5) 0.26
Airway obstruction 6 (12.0) 2 (6.1) 5.9 (−11.1 to 19.8) 0.18
Surgery 1 (2.0) 2 (6.0) −4.0 (− 7.1 to 1.9) 0.16
Cardiac arrest 3 (6.0) 2 (6.1) −0.1 (− 16.2 to 12.5) 0.49
Aspiration 1 (2.0) 1 (3.0) −1.0 (− 5.7 to 7.2) 0.38
Shock 3 (6.0) 2 (6.1) −0.1 (− 10.3 to 10.5) 0.49

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pressure augmentation during spontaneous breathing trials, protocols minimizing

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