Predicting who will need reintubation after a successful breathing trial

The First Affiliated Hospital of Chongqing Medical University

This project will try to combine simple bedside signs to predict which mechanically ventilated adults who pass a spontaneous breathing trial are likely to need reintubation or die within a week.

Quick facts

• Study type: Observational
• Enrollment: 2604 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing)
• Trial ID: NCT05069441 on ClinicalTrials.gov

What this trial studies

This is a prospective observational effort to collect routine bedside and laboratory variables from mechanically ventilated adults who have successfully completed a spontaneous breathing trial and are planned for extubation. Collected data include vital signs, arterial blood gases, cough strength, cuff-leak test results, and use of noninvasive ventilation, among others, with follow-up to 28 days postextubation or hospital discharge. Investigators will analyze predictors of extubation failure (reintubation or death within 7 days), then combine easily obtained variables to develop and validate a bedside risk scale and identify cutoff values for low, moderate, and high risk. The study aims to produce a simple tool usable at the bedside to stratify postextubation risk.

Who should consider this trial

Good fit: Adults (18 years or older) who are mechanically ventilated, have an oral or nasal endotracheal tube, and have successfully completed a spontaneous breathing trial and are prepared for extubation are eligible.

Not a fit: Patients extubated without a spontaneous breathing trial, patients reintubated because of secondary surgery, and those with a tracheotomy are unlikely to benefit from this prediction scale.

Why it matters

Potential benefit: If successful, the scale could help clinicians identify low, moderate, or high risk patients at the bedside and guide decisions to prevent reintubation and related complications.

How similar studies have performed: Prior research has identified individual predictors such as rapid shallow breathing index, cough strength, and cuff-leak tests, but combining these into a validated, widely accepted bedside scale remains novel and not yet established.

Eligibility criteria

Inclusion Criteria:

* Prepared for extubation through spontaneous breathing trial;Oral or nasal endotracheal intubation; be at least 18 years old

Exclusion Criteria:

* Extubation without a spontaneous breathing trial ;Reintubation due to secondary surgery; Tracheotomy

Where this trial is running

Chongqing

• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)

Study contacts

• Principal investigator: Jun Duan — First Affiliated Hospital of Chongqing Medical University
• Study coordinator: Jun Duan, Dr

Conditions Mechanical Ventilation; Extubation Failure