Clinical trial NCT04227639: T-piece Versus Pressure-support for the Spontaneous Breathing Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning From Mechanical Ventilation
Extubation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of ventilator-free days at day 28
timeFrame: Day 28
Secondary outcomes:
measure: 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.
timeFrame: Between Day 1 and Day 28
measure: The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial.
timeFrame: Hour 72, Day 7
measure: The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning
timeFrame: Day 28
measure: The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours.
timeFrame: Hour 72
measure: The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients
timeFrame: Day 28
measure: The number of patients reintubated within the 72 hours and within the 7 days following extubation.
timeFrame: Day 28
measure: The number of patients with post-extubation respiratory failure within the 7 days following extubation.
timeFrame: Day 28
measure: Length of stay in ICU in days.
timeFrame: Day 90
measure: Numbers of patients died in ICU, at day 28 and at day 90.
timeFrame: Day 28 and Day 90
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Intensive reanimation
Study officials:
affiliation: CHU Poitiers
name: Arnaud W. THILLE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26.
citation: Thille AW, Coudroy R, Gacouin A, Ehrmann S, Contou D, Dangers L, Romen A, Guitton C, Lacave G, Quenot JP, Lacombe B, Pradel G, Terzi N, Prat G, Labro G, Reignier J, Beduneau G, Dellamonica J, Nay MA, Rouze A, Delbove A, Sedillot N, Mira JP, Bourenne J, Lautrette A, Argaud L, Levrat Q, Devaquet J, Vivier E, Azais MA, Leroy C, Dres M, Robert R, Ragot S, Frat JP; REVA research network. T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX). BMJ Open. 2020 Nov 24;10(11):e042619. doi: 10.1136/bmjopen-2020-042619.