Clinical Trials Directory

Trials / Completed

CompletedNCT03185962

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

Status
Completed
Phase
Study type
Observational
Enrollment
499 (actual)
Sponsor
Osaka University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2017-05-01
Primary completion
2019-10-31
Completion
2020-08-25
First posted
2017-06-14
Last updated
2021-01-26

Locations

1 site across 1 country: Japan

Source: ClinicalTrials.gov record NCT03185962. Inclusion in this directory is not an endorsement.

Predictors Of Successful Extubation in Critically Ill Patients: Multicentre Observational Study (NCT03185962) · Clinical Trials Directory