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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03185962
Acronym
POSE
Enrollment
499
Registered
2017-06-14
Start date
2017-05-01
Completion date
2020-08-25
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

None listed

Sponsors

Osaka University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implementation of reintubation within 48 hours after extubation48 hourslogistic regression will be used to identify risk factors

Secondary

MeasureTime frameDescription
Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation48 hourslogistic regression will be used to identify risk factors
Length of ICU and hospital stay,28 daysmean(standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate
vital status at ICU and hospital discharge, 28-day mortality28 daysmean(standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026