UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039585 |
|---|---|
| Receipt number | R000045142 |
| Scientific Title | Changes of body pressure with postyre during operation |
| Date of disclosure of the study information | 2020/02/25 |
| Last modified on | 2020/02/24 19:50:01 |
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Basic information
Public title
Changes of body pressure with postyre during operation
Acronym
Changes of body pressure with postyre during operation
Scientific Title
Changes of body pressure with postyre during operation
Scientific Title:Acronym
Changes of body pressure with postyre during operation
Region
| Japan |
Condition
Condition
Long-term surgery under general anesthesia(planned for 4 hours or more)
Classification by specialty
| Anesthesiology | Operative medicine | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evalute changes over time in body pressure,deviation and body temperature using surgical body pressure monitoring mats in target surgical patients.
Basic objectives2
Others
Basic objectives -Others
Whether there are differences in body pressure change depending on body position
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Continuous measurement of body pressure during surgery
Key secondary outcomes
Observe for pressure ulcers until POD3
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
If a value exceeding 100mmHg is detected during body pressure monitoring,depressurize as much as possible
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
General anesthesia
Schedduled for more than 4 hours
Key exclusion criteria
none
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Ishii |
Organization
National center for Global Health and Medicine JAPN
Division name
Department of nursing
Zip code
162-8655
Address
1-21-1 Toyamacho,Shinjuku-City,Tokyo
TEL
0332027181
mishii@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Mitsuko |
| Middle name | |
| Last name | Ishii |
Organization
National center for Global Health and Medicine JAPN
Division name
Department of nursing
Zip code
162-8655
Address
1-21-1 Toyamacho,Shinjuku-City,Tokyo
TEL
0332027181
Homepage URL
mishii@hosp.ncgm.go.jp
Sponsor or person
Institute
National center for Global Health and Medicine JAPN
Institute
Department
Personal name
Funding Source
Organization
National center for Global Health and Medicine JAPN
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
IRB,National center for Global Health and Medicine JAPAN
Address
1-21-1 Toyamacho,Shinjuku-City,Tokyo
Tel
0332027181
mishii@hosp.ncgm.go.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
| 2020 | Year | 02 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 24 | Day |
Last modified on
| 2020 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045142
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
