UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032462 |
|---|---|
| Receipt number | R000036942 |
| Scientific Title | PRONE POSITIONING AND SPONTANEOUS BREATHING: A FEASIBILITY STUDY |
| Date of disclosure of the study information | 2018/05/30 |
| Last modified on | 2020/06/17 11:35:40 |
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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
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
auchiyama@hp-icu.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Institute
Department
Personal name
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
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
12
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 08 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 08 | 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
| 2020 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036942
