Spontaneous Breathing Trials Using Pressure Support or T-... | NCT07114289

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2025Actual

Primary Completion Date

Mar 31, 2027Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

Aug 4, 2025

First Submission Date that Met QC Criteria

Aug 4, 2025

First Posted Date

Aug 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Spontaneous breathing trial using pressure support ventilation	Procedure	Patients will receive low level pressure support ventilation for 1 hour before extubation	PSV group

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

Eligibility Module

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:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009765	Obesity
D050177	Overweight
D012131	Respiratory Insufficiency

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases