Spontaneous Breathing Trials Using Pressure Support or T-Piece in Overweight and Obese Patients

Taipei Medical University

Status: Begins enrollment this month

Conditions: Obesity &Amp; Overweight; Respiratory Failure; Mechanical Ventilation; Extubation

Treatments: Procedure: Spontaneous breathing trial using T-Piece; Procedure: Spontaneous breathing trial using pressure support ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07114289

N202412012

Details and patient eligibility

About

This study aims to find out which method of spontaneous breathing trial (SBT) better helps overweight and obese ICU patients prepare for extubation, which is the removal of the breathing tube. The two methods being compared are pressure support ventilation (PSV) and the T-piece.

Participants are adults with a body mass index (BMI) of 25 or higher who have been on a breathing machine (invasive mechanical ventilation) for more than 24 hours. Before removing the breathing tube, participants will be randomly assigned to receive either a PSV or a T-piece trial for 1 hour. After that, doctors will decide if they are ready for extubation.

The main question this study wants to answer is: Which method leads to a higher rate of successful extubation-defined as not needing to be reintubated within 72 hours?

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients had undergone intubation and mechanical ventilation for more than 24 hours prior to the first spontaneous breathing trial.

2. Adult patients aged ≥ 18 years. 3. BMI ≥ 25 kg/m². 4. Meeting all the Inter national Consensus Conference on weaning criteria:

3. Stable vital signs: heart rate < 140 beats/min, systolic blood pressure: 90-160 mmHg, and no use of vasopressors or use of minimal doses (<0.2 µg/kg per min).

4. Respiratory rate ≤ 35 breaths/min.

5. Adequate oxygenation, defined as either SpO2 > 90% with FiO2 ≤ 0.4, or PaO2/FiO2 > 150 mmHg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O.

6. Adequate cough strength (MIP < -20 cmH2O).

7. An awake state, defined as a score of Richmond Agitation-Sedation Scale between +1 and -2, or Glasgow Coma Scale > 8.

8. No continuous sedation. 5. Informed consent provided by the patient or their relatives.

Exclusion criteria

1. Patients with tracheostomy.
2. Patients who had been admitted for traumatic brain injury.
3. Patients who had preexisting peripheral neuromuscular disease (underlying myopathy or myasthenia gravis).
4. Patients who had a do-not-reintubate order at the time of the initial spontaneous breathing trial were excluded
5. Patients who have already undergone a first spontaneous breathing trial.
6. Patients who had undergone extubation without an SBT
7. Protected populations: pregnant or breastfeeding women, individuals under guardianship, or those under legal protection.
8. Patients who refused to participate during the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

PSV group

Active Comparator group

Treatment:

Procedure: Spontaneous breathing trial using pressure support ventilation

T-Piece group

Active Comparator group

Treatment:

Procedure: Spontaneous breathing trial using T-Piece