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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030416
Receipt No. 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

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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 Obsterics 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
Email 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
Email takatoru@fhw.oka-pu.ac.jp

Sponsor
Institute Okayama Prefectural University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034702

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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