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Recruiting NCT05069441

Prediction of Extubation Failure: A Multicenter Prospective Observational Study

Observational Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mechanical Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The First Affiliated Hospital of Chongqing Medical University

Overview

The investigators intend to collect several variables to predict extubation failure among patients who successfully complete a spontaneous breathing trial, and then develop a scale using simple bedside indicators to predict extubation failure.

Detailed description

Mechanically ventilated patients who successfully completed a spontaneous breathing trial and prepared for extubation are eligible to enroll in this study. The vital signs, arterial blood gas tests, cough strength, cuff leak test, use of noninvasive ventilation et al. are collected. Patients are followed up to postextubation 28-day or discharge. Extubation failure is defined as reintubatin or death within postextubation 7 days. First, we will analyze the data to predict extubation failure. Then, we will combine several easily obtained variables to develop and validate a scale to predict extubation failure. Finally, we explore the predictive power of extubation failure tested by the scale and find the cutoff value to distinguish the low, moderate and high risk of extubation failure.

Primary outcome measures

  • Rate of extubation failure [Time frame: From extubation to 48 hours]
  • Rate of extubation failure [Time frame: From extubation to 7 days]
  • Rate of extubation failure [Time frame: From extubation to 28 days]
Secondary outcome measures (2)
  • Rate of mortality [Time frame: From extubation to 28 days]
  • ICU stay [Time frame: From extubation to 28 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing

Identifiers

NCT: NCT05069441 · ChongqingMU4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗