Predictors Of Successful Extubation in Critically Ill Patients: Multicentre Observational Study

Completed

• Conditions: Extubation; Intubation; Weaning; Critical Care; Mechanical Ventilation; Liberation From Mechanical Ventilation

• Registration Number: NCT03185962
• Lead Sponsor: Osaka University

Brief Summary

Extubation failure can directly worsen patient outcomes. Therefore, the decision to extubate is a critical moment during an intensive care unit (ICU) stay. The decision to extubate is usually made after a weaning readiness test involving spontaneous breathing on a T-piece or low levels of ventilatory assistance. However, extubation failure still occurs in 10 to 20% of patients. The investigators focused on previously reported physiological risk factors, and were able to obtain from common clinical practice: 1) age, 2) underlying cardiovascular disease, 3) underlying respiratory disease or occurrence of pneumonia, 4) rapid shallow breathing index (RSBI), 5) positive fluid balance during the previous 24 hours, 6) the ratio of arterial oxygen partial pressure to fractional inspired oxygen, 7) Glasgow Coma Scale, 8) respiratory tract secretions. The investigators aimed to assess the incidence and risk factors for extubation failure among critically ill patients who passed the 30 min spontaneous breathing test (SBT) using a low level of pressure support (PS) with positive end-expiratory pressure (PEEP), in a prospective multicenter study.

Detailed Description

Primary Outcome Measures:

Reintubation within 48 hours after extubation (logistic regression will be used to assess the risk factors)

Secondary Outcome Measures:

* Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation.

* Risk factors for extubation failure, with quantitative variables expressed as means (standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate

* Length of ICU and hospital stay, vital status at ICU and hospital discharge, 28-day mortality

Study Timeline

• Study First Submitted: 2017-04-28
• Study Start: 2017-05-01
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Primary Completion: 2019-10-31
• Study Completion: 2020-08-25
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

Inclusion Criteria

• Mechanically ventilated for longer than 24 hours in Intensive Care Units
• Extubated after successful the 30 min spontaneous breathing test using a low level of pressure support with positive end-expiratory pressure

Exclusion Criteria

• Decision not to reintubate
• Unplanned extubation
• Extracorporeal circulation
• Patients who died within 48 hours after extubation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implementation of reintubation within 48 hours after extubation	48 hours	logistic regression will be used to identify risk factors

Secondary Outcome Measures

Name	Time	Method
vital status at ICU and hospital discharge, 28-day mortality	28 days	mean(standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate
Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation	48 hours	logistic regression will be used to identify risk factors
Length of ICU and hospital stay,	28 days	mean(standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Osaka University; 🇯🇵 Suita, Osaka, Japan