IntubationPOSENCT03185962
Predictors Of Successful Extubation in Critically Ill Patients: Multicentre Observational Study
An observational study of Intubation and Extubation, run by Osaka University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Extubation, Weaning
- How many people
- 499 participants
- Where
- 1 siteJapan
- Study dates
- 1 May 2017to 25 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients extubated in the ICU
Who may be able to join
- 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
Who cannot join
- Decision not to reintubate
- Unplanned extubation
- Extracorporeal circulation
- Patients who died within 48 hours after extubation
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Suita, Osaka, 565-0871
About this 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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Successful extubation | extubated successfully | |
| Extubation failure | reintubated within 48 hours | |
| NPPV/NHF | use of non-invasive positive pressure ventilation (NPPV) or nasal high flow (NHF) within 48 hours after extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of reintubation within 48 hours after extubation
logistic regression will be used to identify risk factors
Measured: 48 hours
Secondary outcomes (3)
Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation
logistic regression will be used to identify risk factors
Measured: 48 hours
Length of ICU and hospital stay,
mean(standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate
Measured: 28 days
vital status at ICU and hospital discharge, 28-day mortality
mean(standard deviation) or medians (interquartiles 25%-75%) and compared using the student t test or Wilcoxon test as appropriate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 May 2017
- Primary completion31 Oct 2019
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuji Fujino, Study chair, Department of Anesthesiology and Intensive Care Medicine, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185962
- Sponsor's protocol ID
- POSE
- Acronym
- POSE
- Status last verified
- Jan 2021
- First submitted
- 28 Apr 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors Of Successful Extubation in Critically Ill Patients: Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT03185962
- Acronym / sponsor ID
- POSE / POSE
- Conditions
- Intubation, Extubation, Weaning, Mechanical Ventilation, Liberation From Mechanical Ventilation, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Successful extubation | – | –extubated successfully |
| Extubation failure | – | –reintubated within 48 hours |
| NPPV/NHF | – | –use of non-invasive positive pressure ventilation (NPPV) or nasal high flow (NHF) within 48 hours after extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients extubated in the ICU
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Decision not to reintubate
- Unplanned extubation
- Extracorporeal circulation
- Patients who died within 48 hours after extubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implementation of reintubation within 48 hours after extubation
Time frame: 48 hours
logistic regression will be used to identify risk factors
3 secondary outcomes
Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation
Time frame: 48 hours
Length of ICU and hospital stay,
Time frame: 28 days
vital status at ICU and hospital discharge, 28-day mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuji Fujino study chair
Department of Anesthesiology and Intensive Care Medicine, Osaka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation and Extubation, run by Osaka University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation of reintubation within 48 hours after extubation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.