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Clinical Trials/NCT03185962
NCT03185962
Completed
Not Applicable

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

Osaka University1 site in 1 country499 target enrollmentMay 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation
Sponsor
Osaka University
Enrollment
499
Locations
1
Primary Endpoint
Implementation of reintubation within 48 hours after extubation
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
August 25, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Implementation of reintubation within 48 hours after extubation

Time Frame: 48 hours

logistic regression will be used to identify risk factors

Secondary Outcomes

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

Study Sites (1)

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