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

Not Applicable

Completed

• Conditions: Weaning From Mechanical Ventilation; Extubation
• Interventions: Procedure: Pressure-support trial; Procedure: T-piece trial

• Registration Number: NCT04227639
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-01-31
• Primary Completion: 2021-06-07
• Study Completion: 2021-09-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Duration of mechanical ventilation prior to the first spontaneous brathing trial > 24h

2. 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.

3. 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).

4. Informed consent given by the relatives or the patient himself.

Exclusion Criteria

1. Patients admitted for traumatic brain injury
2. Pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis)
3. Do-not-reintubate order at time of the first spontaneous breathing trial
4. Patient previously included in the study
5. No Health insurance coverage
6. People under protection: Pregnant or breastfeeding women, minor patients, subjects with guardianship or under law protection.
7. Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure-Support trial	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.
T-piece trial	T-piece trial	In patients assigned to control group all spontaneous breathing trials will be performed using T-piece trial.

Primary Outcome Measures

Name	Time	Method
Number of ventilator-free days at day 28	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.

Secondary Outcome Measures

Name	Time	Method
The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients	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.	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
Numbers of patients died in ICU, at day 28 and at day 90.	Day 28 and Day 90
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

Trial Locations

Locations (1)

Intensive reanimation; 🇫🇷 Poitiers, France