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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040924
Receipt No. R000046715
Scientific Title Study on the monitoring of body pressure for prevention of neuropathy and pressure ulcer during operation
Date of disclosure of the study information 2020/08/31
Last modified on 2020/06/28

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Basic information
Public title Study on the monitoring of body pressure for prevention of neuropathy and pressure ulcer during operation
Acronym Study on the monitoring of body pressure for prevention of neuropathy and pressure ulcer during operation
Scientific Title Study on the monitoring of body pressure for prevention of neuropathy and pressure ulcer during operation
Scientific Title:Acronym Study on the monitoring of body pressure for prevention of neuropathy and pressure ulcer during operation
Region
Japan

Condition
Condition Long-term surgery under general anesthesia (planned for 2 hours or more)
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the relationship of changes of body pressure during surgery and postoperative neuropathy and pressure ulcer using pressure monitoring mat.
Basic objectives2 Others
Basic objectives -Others Whether there are differences in body pressure depending on the position during surgery.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between intraoperative body pressure and postoperative neuropathy and pressure ulcer until the postoperative day 4.
Key secondary outcomes Difference in pressure due to position during surgery

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
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 pressure 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
Scheduled for more than 2 hours
Key exclusion criteria none
Target sample size 210

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Maehara
Organization National Center for Global Health and Medicine JAPAN
Division name Department of Anesthesiology
Zip code 162-8655
Address 1-21-1 Toyama, Shinjuku-City, Tokyo
TEL 0332027181
Email ymaehara@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Maehara
Organization National Center for Global Health and Medicine JAPAN
Division name Department of Anesthesiology
Zip code 162-8655
Address 1-21-1 Toyama, Shinjuku-City, Tokyo
TEL 0332027181
Homepage URL
Email ymaehara@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine JAPAN
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine JAPAN
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 Cneter of Global Health and Medicine JAPAN
Address 1-21-1 Toyama, Shinjuku-City, Tokyo
Tel 0332027181
Email ymaehara@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 国立国際医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 31 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 122
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason It is difficult to interpret intraoperative pressure monitoring data due to lack of past reports. The analysis is time consuming due to the complexity of data.
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 Completed
Date of protocol fixation
2017 Year 10 Month 05 Day
Date of IRB
2017 Year 10 Month 10 Day
Anticipated trial start date
2017 Year 11 Month 07 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2020 Year 07 Month 20 Day
Date trial data considered complete
2020 Year 07 Month 31 Day
Date analysis concluded
2020 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 06 Month 28 Day
Last modified on
2020 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046715

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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