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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 499

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Department of Anesthesiology and Intensive Care Medicine, Osaka University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients extubated in the ICU

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Successful extubation; extubated successfully
Extubation failure; reintubated within 48 hours
NPPV/NHF; use of non-invasive positive pressure ventilation (NPPV) or nasal high flow (NHF) within 48 hours after extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation of reintubation within 48 hours after extubation	logistic regression will be used to identify risk factors	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Osaka University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: POSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No