UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030416 |
|---|---|
| Receipt number | R000034702 |
| Scientific Title | The study on the safe positioning of the patients subjected to surgical operation |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2017/12/15 15:20:30 |
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Basic information
Public title
The study on the safe positioning of the patients subjected to surgical operation
Acronym
Safe positioning of the patients with surgical operation
Scientific Title
The study on the safe positioning of the patients subjected to surgical operation
Scientific Title:Acronym
Safe positioning of the patients with surgical operation
Region
| Japan |
Condition
Condition
Patients subjected to surgical operartion
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Ophthalmology |
| Orthopedics | Urology | Anesthesiology |
| Neurosurgery | Cardiovascular surgery | Plastic surgery |
| Laboratory medicine | Operative medicine | Emergency medicine |
| Intensive care medicine | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to analyze the relationship between dynamic parameters to the body and physiological parameters during surgery in order to give safe position to the surgical patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
After having been in surgical position for 5 minutes, the subjects remained in the same position for an additional minute while the measurements were being performed. The participants were kept awake throughout.
Primary outcome
Peak contact pressure
Key secondary outcomes
total force
contact pressure
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
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
From July 1, 2015 to August 31, 2020
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Adults
Key exclusion criteria
Thsoe who have anu disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Takahashi |
Organization
Okayama Prefectural University
Division name
Health and Welfare Science
Zip code
Address
111, Kuboki, Soja City, Okayama
TEL
0866-94-2175
takatoru@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Takahashi |
Organization
Okayama Prefectural University
Division name
Health and Welfare Science
Zip code
Address
111, Kuboki, Soja City, Okayama
TEL
0866-94-2175
Homepage URL
takatoru@fhw.oka-pu.ac.jp
Sponsor or person
Institute
Okayama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Okayama Prefectural University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
岡山県立大学保健福祉学部
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2017 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034702
