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

Mechanical Ventilation Clinical Trial

— POSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185962
• Other study ID #: POSE
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: August 25, 2020

Study information

• Verified date: January 2021
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: August 25, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Extubation
• Intubation
• Liberation From Mechanical Ventilation
• Mechanical Ventilation
• Weaning

Locations

Country	Name	City	State
Japan	Department of Anesthesiology and Intensive Care Medicine, Osaka University	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka University

Country where clinical trial is conducted

Japan, 

Outcome

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