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

NCT ID: NCT03185962

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 499 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2020-08-25

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Successful extubation

extubated successfully

No interventions assigned to this group

Extubation failure

reintubated within 48 hours

No interventions assigned to this group

NPPV/NHF

use of non-invasive positive pressure ventilation (NPPV) or nasal high flow (NHF) within 48 hours after extubation

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osaka University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuji Fujino

Role: STUDY_CHAIR

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Locations

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Suita, Osaka, Japan

Countries

Japan

Other Identifiers

POSE

Identifier Type: -

Identifier Source: org_study_id