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

NCT04227639 | Completed

• 2 other identifiers: TiP-Ex2019-A02151-56
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning From Mechanical Ventilation; Extubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

T-piece trial

ACTIVE COMPARATOR

In patients assigned to control group all spontaneous breathing trials will be performed using T-piece trial.

Procedure: T-piece trial

Pressure-Support trial

EXPERIMENTAL

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

Interventions

T-piece trial PROCEDURE

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)

T-piece trial

Pressure-support trial PROCEDURE

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.

Pressure-Support trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Intensive reanimation

Poitiers, 86000, France

Location

Related Publications (4)

• Metais M, Frat JP, Ehrmann S, Pene F, Decavele M, Terzi N, Prat G, Martin M, Contou D, Gacouin A, Bourenne J, Girault C, Vinsonneau C, Dellamonica J, Labro G, Jochmans S, Herbland A, Quenot JP, Devaquet J, Benzekri D, Ragot S, Thille AW, Coudroy R; FLORALI-IM study group and the REVA Research Network. Factors associated with ICU mortality and long-term outcomes in immunocompromised patients admitted to the intensive care unit for acute respiratory failure. Ann Intensive Care. 2025 Oct 30;15(1):175. doi: 10.1186/s13613-025-01578-1.

  PMID: 41168567 DERIVED

• Coudroy R, Lejars A, Rodriguez M, Frat JP, Rault C, Arrive F, Le Pape S, Thille AW. Physiologic Effects of Reconnection to the Ventilator for 1 Hour Following a Successful Spontaneous Breathing Trial. Chest. 2024 Jun;165(6):1406-1414. doi: 10.1016/j.chest.2024.01.038. Epub 2024 Jan 29.

  PMID: 38295948 DERIVED

• 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.

  PMID: 36286317 DERIVED

• 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.

  PMID: 33234658 DERIVED

Study Officials

• Arnaud W. THILLE, Pr

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: January 31, 2020
• Primary Completion: June 7, 2021
• Study Completion: September 7, 2021
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)