UMIN-CTR Clinical Trial

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