T-piece Versus Pressure-support for the Spontaneous Breathing Trial (TiP-Ex)
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|ClinicalTrials.gov Identifier: NCT04227639|
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials.
To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit.
Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.
|Condition or disease||Intervention/treatment||Phase|
|Weaning From Mechanical Ventilation Extubation||Procedure: T-piece trial Procedure: Pressure-support trial||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||T-piece Versus Pressure-support for the Spontaneous Breathing Trial Before Extubation in Patients at High-risk of Reintubation: a Multicenter Randomized Controlled Trial|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Active Comparator: T-piece trial
In patients assigned to control group all spontaneous breathing trials will be performed using T-piece trial.
Procedure: T-piece trial
T-piece trial will be performed for around 1 hour with a T-piece connected to the extremity of the endotracheal tube by simply disconnecting the patient from the ventilator and by providing additional oxygen (≤ 6 L/min)
Experimental: Pressure-Support trial
In patients assigned to experimental group all spontaneous breathing trials will be performed with a pressure-support level of 8 cm H2O without positive end-expiratory pressure.
Procedure: Pressure-support trial
Pressure-Support trial will be performed for around 1 hour without disconnecting the patient from the ventilator, by using a low level of pressure-support (PS 8 cm H2O) with a FiO2 ≤ 40% and without positive end-expiratory pressure (PEEP), while continuously monitoring the respiratory rate and tidal volume on the ventilator display.
- Number of ventilator-free days at day 28 [ Time Frame: Day 28 ]The number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation (intubation or tracheostomy) between the first spontaneous breathing trial (day 1) and day 28.
- The number of days alive and without mechanical ventilation (including intubation or non-invasive ventilation) between the first spontaneous breathing trial (day 1) and day 28. [ Time Frame: Between Day 1 and Day 28 ]
- The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial. [ Time Frame: Hour 72, Day 7 ]
- The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning [ Time Frame: Day 28 ]
- The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours. [ Time Frame: Hour 72 ]
- The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients [ Time Frame: Day 28 ]
- The number of patients reintubated within the 72 hours and within the 7 days following extubation. [ Time Frame: Day 28 ]
- The number of patients with post-extubation respiratory failure within the 7 days following extubation. [ Time Frame: Day 28 ]
- Length of stay in ICU in days. [ Time Frame: Day 90 ]
- Numbers of patients died in ICU, at day 28 and at day 90. [ Time Frame: Day 28 and Day 90 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227639
|Contact: Arnaud W. THILLE, Pr||0549446064 ext +firstname.lastname@example.org|
|Contact: Céline DELETAGEemail@example.com|
|Poitiers, France, 86000|
|Principal Investigator:||Arnaud W. THILLE, Pr||CHU Poitiers|