T-piece Versus Pressure-support for the Spontaneous Breathing Trial (TiP-Ex)

May 11, 2022 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86000
        • Intensive reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 28

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: Between 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.
Time Frame: Hour 72, Day 7
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
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
Hour 72
The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients
Time Frame: Day 28
Day 28
The number of patients reintubated within the 72 hours and within the 7 days following extubation.
Time Frame: Day 28
Day 28
The number of patients with post-extubation respiratory failure within the 7 days following extubation.
Time Frame: Day 28
Day 28
Length of stay in ICU in days.
Time Frame: Day 90
Day 90
Numbers of patients died in ICU, at day 28 and at day 90.
Time Frame: Day 28 and Day 90
Day 28 and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Arnaud W. THILLE, Pr, CHU Poitiers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2020

Primary Completion (Actual)

June 7, 2021

Study Completion (Actual)

September 7, 2021

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • TiP-Ex
  • 2019-A02151-56 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be made available after reasonable request and it has been discussed among the steering committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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