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

NCT07114289 | Recruiting

• 1 other identifier: N202412012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Successful extubation within 72 hours

  Within 72 hours after extubation

Study Arms (2)

PSV group

ACTIVE COMPARATOR

Procedure: Spontaneous breathing trial using pressure support ventilation

T-Piece group

ACTIVE COMPARATOR

Procedure: Spontaneous breathing trial using T-Piece

Interventions

Spontaneous breathing trial using pressure support ventilation PROCEDURE

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

PSV group

Spontaneous breathing trial using T-Piece PROCEDURE

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

T-Piece group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients had undergone intubation and mechanical ventilation for more than 24 hours prior to the first spontaneous breathing trial.
• \. Adult patients aged ≥ 18 years. 3. BMI ≥ 25 kg/m². 4. Meeting all the Inter national Consensus Conference on weaning criteria:
• 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).
• Respiratory rate ≤ 35 breaths/min.
• Adequate oxygenation, defined as either SpO2 \> 90% with FiO2 ≤ 0.4, or PaO2/FiO2 \> 150 mmHg with positive end-expiratory pressure (PEEP) ≤ 8 cmH2O.
• Adequate cough strength (MIP \< -20 cmH2O).
• An awake state, defined as a score of Richmond Agitation-Sedation Scale between +1 and -2, or Glasgow Coma Scale \> 8.
• No continuous sedation. 5. Informed consent provided by the patient or their relatives.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Respiratory therapist

CONTACT

+886-937870463; lynnho0326@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-05

Locations

TW (1)