UMIN-CTR Clinical Trial

Basic information
Public title	Predictors Of Successful Extubation in critically ill patients: multicentre observational study
Acronym	POSE
Scientific Title	Predictors Of Successful Extubation in critically ill patients: multicentre observational study
Scientific Title:Acronym	POSE
Region	Japan

Condition
Condition	Intubation in Intensive Care Units
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the incidence and risk factors for extubation failure among critically ill patients who passed the 30 min spontaneous breathing test
Basic objectives2	Others
Basic objectives -Others	To establish the predict model of the successful extubation
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Reintubation within 48 hours after extubation
Key secondary outcomes	-Use of non-invasive positive pressure ventilation or nasal high flow within 48 hours after extubation -Risk factors for extubation failure -Length of ICU and hospital stay, vital status at ICU and hospital discharge

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	200 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult patients extubated after successful spontaneous breathing test in the ICU
Key exclusion criteria	-Decision not to reintubate -Unplanned extubation -Extracorporeal circulation -Patients who died within 48 hours after extubation
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Fujino
Organization	Osaka University
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	5650871
Address	2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL	06-6879-5820
Email	fujino@anes.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Fujino
Organization	Osaka University
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	5650871
Address	2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL	06-6879-5820
Homepage URL
Email	fujino@anes.med.osaka-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Intensive Care Medicine, Osaka University
Institute
Department

Funding Source
Organization	Department of Anesthesiology and Intensive Care Medicine, Osaka University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka university
Address	2-2 Yamadaoka Suita city Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	513
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	none
Outcome measures
Plan to share IPD
IPD sharing Plan description	EDC: REDCap

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 03 Month 27 Day
Date of IRB	2017 Year 03 Month 27 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry	2019 Year 10 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Recruitment: patients admitted to ICU until April 30, 2019 Study Completion (anticipated): March 31, 2021

Management information
Registered date	2017 Year 04 Month 30 Day
Last modified on	2020 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031163