T-piece Versus Pressure-support for the Spontaneous Breathing Trial

Study Overview
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Brief Summary
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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.

Official Title
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T-piece Versus Pressure-support for the Spontaneous Breathing Trial Before Extubation in Patients at High-risk of Reintubation: a Multicenter Randomized Controlled Trial

Conditions
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Weaning From Mechanical Ventilation, Extubation

Intervention / Treatment
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* Procedure: T-piece trial
* Procedure: Pressure-support trial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Duration of mechanical ventilation prior to the first spontaneous brathing trial > 24h Patients at high-risk of reintubation according to the following criteria: Patients older than 65 years, or those having any underlying chronic cardiac or lung disease. Patient meeting all weaning criteria according to the international conference consensus on weaning. Respiratory rate ≤ 35 breaths per minute, Adequate oxygenation defined as SpO2 > 90% with FiO2 ≤ 0.4 or PaO2/FiO2 > 150 mm Hg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O, Adequate cough, Patient awake with a Richmond Agitation-Sedation Scale between +1 and -2 No continuous sedation, Hemodynamic stability with no need for vasopressors (or minimal dosis). Informed consent given by the relatives or the patient himself. Exclusion Criteria: Patients admitted for traumatic brain injury Pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis) Do-not-reintubate order at time of the first spontaneous breathing trial Patient previously included in the study No Health insurance coverage People under protection: Pregnant or breastfeeding women, minor patients, subjects with guardianship or under law protection. Refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T-piece trial<br>In patients assigned to control group all spontaneous breathing trials will be performed using T-piece trial. | Procedure: T-piece trial<br>* 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)<br>|
| Experimental: Pressure-Support trial<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilator-free days at 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. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |  | Hour 72, Day 7 | 
| The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning |  | Day 28 | 
| The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours. |  | Hour 72 | 
| The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients |  | Day 28 | 
| The number of patients reintubated within the 72 hours and within the 7 days following extubation. |  | Day 28 | 
| The number of patients with post-extubation respiratory failure within the 7 days following extubation. |  | Day 28 | 
| Length of stay in ICU in days. |  | Day 90 | 
| Numbers of patients died in ICU, at day 28 and at day 90. |  | Day 28 and Day 90 |