UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040924 |
|---|---|
| Receipt number | 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 14:11:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ymaehara@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine JAPAN
Institute
Department
Personal name
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
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
Value
https://center6.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 |
