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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-09-07

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.

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Detailed Description

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Conditions

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Weaning From Mechanical Ventilation Extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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T-piece trial

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

Group Type ACTIVE_COMPARATOR

T-piece trial

Intervention Type 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)

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.

Group Type EXPERIMENTAL

Pressure-support trial

Intervention Type 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.

Interventions

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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)

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No