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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032462
Receipt No. R000036942
Scientific Title PRONE POSITIONING AND SPONTANEOUS BREATHING: A FEASIBILITY STUDY
Date of disclosure of the study information 2018/05/30
Last modified on 2019/05/09

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Basic information
Public title PRONE POSITIONING AND SPONTANEOUS BREATHING: A FEASIBILITY STUDY
Acronym The PROSE study
Scientific Title PRONE POSITIONING AND SPONTANEOUS BREATHING: A FEASIBILITY STUDY
Scientific Title:Acronym The PROSE study
Region
Japan North America South America

Condition
Condition acute respiratory distress syndrome
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility to initiate and maintain spontaneous breathing while patients are under prone positioning.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes the strength of spontaneous breathing
Key secondary outcomes Esophageal pressure, electrical activation of the diaphragm,lung volume, cytokines

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 prone positioning with and without muscle paralysis
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
99 years-old >=
Gender Male and Female
Key inclusion criteria Patients with moderate-to-severe ARDS as per the Berlin definition (PaO2/FiO2 < 200 mmHg)
Key exclusion criteria Contraindication for prone positioning
Target sample size 6

Research contact person
Name of lead principal investigator
1st name Akinori
Middle name
Last name Uchiyama
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 +81-6-6879-5820
Email auchiyama@hp-icu.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Akinori
Middle name
Last name Uchiyama
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 +81-6-6879-5820
Homepage URL
Email auchiyama@hp-icu.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 Academic Clinical Research Center of Osaka University
Address 2-2 Yamadaoka Suita, Osaka, 565-0871 JAPAN
Tel 06-6210-8290
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 Department of Anesthesiology and Intensive Care Medicine, Osaka University

Other administrative information
Date of disclosure of the study information
2018 Year 05 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 15 Day
Date of IRB
2018 Year 10 Month 22 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 02 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036942

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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