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

Comparison of Pressure Support Ventilation and T-Piece as Spontaneous Breathing Trials Before Extubation Among Obese and Overweight Patients

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?

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Extubation; Mechanical Ventilation; Obesity &Amp; Overweight
• Intervention / Treatment: Procedure: Spontaneous breathing trial using pressure support ventilation; Procedure: Spontaneous breathing trial using T-Piece

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Respiratory therapist; Phone Number: +886-937870463; Email: lynnho0326@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University Hospital
    • Contact: Ho; Phone Number: +886937870463; Email: 124057@h.tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PSV group	Procedure: Spontaneous breathing trial using pressure support ventilation; Patients will receive low level pressure support ventilation for 1 hour before extubation
Active Comparator: T-Piece group	Procedure: Spontaneous breathing trial using T-Piece; Patients will receive a T-piece with oxygen for 1 hour before extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful extubation within 72 hours	Within 72 hours after extubation

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: August 4, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Respiratory Insufficiency
• Other Study ID Numbers: N202412012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No