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

NCT03185962 | Completed

• 1 other identifier: POSE
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Extubation; Weaning; Mechanical Ventilation; Liberation From Mechanical Ventilation; Critical Care

Outcome Measures

Primary Outcomes (1)

• Implementation of reintubation within 48 hours after extubation

  logistic regression will be used to identify risk factors

  48 hours

Secondary Outcomes (3)

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

  48 hours

• Length of ICU and hospital stay,

  28 days

• vital status at ICU and hospital discharge, 28-day mortality

  28 days

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients extubated in the ICU

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Osaka University: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Suita, Osaka, 565-0871, Japan

Location

Study Officials

• Yuji Fujino

  Department of Anesthesiology and Intensive Care Medicine, Osaka University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: June 14, 2017
• Study Start: May 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: August 25, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)