Clinical trial NCT03185962: Predictors Of Successful Extubation in Critically Ill Patients: Multicentre Observational Study
Official title: Predictors Of Successful Extubation in Critically Ill Patients: Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Extubation
Weaning
Mechanical Ventilation
Liberation From Mechanical Ventilation
Critical Care
Lead sponsor: Osaka University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients extubated in the ICU

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

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

Primary outcomes:
measure: Implementation of reintubation within 48 hours after extubation
timeFrame: 48 hours
Secondary outcomes:
measure: Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation
timeFrame: 48 hours
measure: Length of ICU and hospital stay,
timeFrame: 28 days
measure: vital status at ICU and hospital discharge, 28-day mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Department of Anesthesiology and Intensive Care Medicine, Osaka University
state: Osaka
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Osaka University
name: Yuji Fujino
role: STUDY_CHAIR
References: