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

NCT ID: NCT07114289

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2027-07-31

Brief Summary

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?

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PSV group

Group Type: ACTIVE_COMPARATOR

Spontaneous breathing trial using pressure support ventilation

Intervention Type: PROCEDURE

Patients will receive low level pressure support ventilation for 1 hour before extubation

T-Piece group

Group Type: ACTIVE_COMPARATOR

Spontaneous breathing trial using T-Piece

Intervention Type: PROCEDURE

Patients will receive a T-piece with oxygen for 1 hour before extubation

Interventions

Spontaneous breathing trial using pressure support ventilation

Patients will receive low level pressure support ventilation for 1 hour before extubation

Intervention Type: PROCEDURE

Spontaneous breathing trial using T-Piece

Patients will receive a T-piece with oxygen for 1 hour before extubation

Intervention Type: PROCEDURE

Eligibility Criteria

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:

1. 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).

2. Respiratory rate ≤ 35 breaths/min.

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

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

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

6. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Respiratory therapist

Role: CONTACT

lynnho0326@gmail.com

+886-937870463

Facility Contacts

Ho

Role: primary

124057@h.tmu.edu.tw

+886937870463

Other Identifiers

N202412012

Identifier Type: -

Identifier Source: org_study_id