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

Poitiers University Hospital

Status: Completed

Conditions: Extubation; Weaning From Mechanical Ventilation

Treatments: Procedure: T-piece trial; Procedure: Pressure-support trial

Study type: Interventional

Funder types: Other

Identifiers

NCT04227639

TiP-Ex

2019-A02151-56 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

T-piece trial

Active Comparator group

Description:

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

Treatment:

Procedure: T-piece trial

Pressure-Support trial

Experimental group

Description:

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.

Treatment:

Procedure: Pressure-support trial