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NCT Number: NCT03185962

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

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.

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Key information

Conditions

Intubation Critical Care Extubation Liberation From Mechanical Ventilation Mechanical Ventilation Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Suita, Osaka, 565-0871, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Implementation of reintubation within 48 hours after extubation

    Time frame: 48 hours

    logistic regression will be used to identify risk factors

Secondary outcomes

  1. Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation

    Time frame: 48 hours

    logistic regression will be used to identify risk factors

  2. Length of ICU and hospital stay,

    Time frame: 28 days

    mean(standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate

  3. vital status at ICU and hospital discharge, 28-day mortality

    Time frame: 28 days

    mean(standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate

Sponsors and collaborators

Lead sponsor

Osaka University

Other

Registry information

Acronym: POSE

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 14, 2017
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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