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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026500
Receipt No. R000030433
Scientific Title Influence of head-down position on fingertip and forehead pulse oximetry
Date of disclosure of the study information 2017/03/10
Last modified on 2017/11/13

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Basic information
Public title Influence of head-down position on fingertip and forehead pulse oximetry
Acronym Influence of head-down position on fingertip and forehead pulse oximetry
Scientific Title Influence of head-down position on fingertip and forehead pulse oximetry
Scientific Title:Acronym Influence of head-down position on fingertip and forehead pulse oximetry
Region
Japan

Condition
Condition none
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hypothermia, hypotension, and peripheral vasoconstriction can reduce the pulse size of pulse oximetry and lead to absent or erroneous oxygen saturation readings at the fingertips. In these situations, the forehead could be better alternative site to monitor oxygen saturation. However, forehead pulse oximetry relates to lower oxygen saturation readings under head-down position. We research the change of oxgen saturation readings at fingertip and forehead in healthy volunteers in head-down position.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of forehead pulse oximetry in head-down position
Key secondary outcomes venous engorgement, facial flush

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The heathy adult volunteers were studied using pulse sensor in the forehead and in the fingertip under head-down positions. First, SpO2 was checked in supine position. Second, subjects were rotated to 10 degree head-down position, kept it for 5 min, and data were checked. Subjects were returned to supine position for 5 min between the two inclined positions to eliminate transient venous pooling. If oxygen saturation in the forehead decreased less than 3% compared to supine position, they were tiled 2 degree more head-down position. If oxygen saturation in the forehead decreased more than 3% compared to supine position, they returned 2 degree back to supine position. We cheaked maximal angular degrees of head-down rotation, which oxygen saturation in the forehead was declined within 3% compared to supine position.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthcare workers who work in operation room at Sumitomo hospital
Key exclusion criteria ASA physical status over three
The history of cerebro-vascular disease
The history of heart failure
Full stomach
The history of glaucoma
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoko Shimizu
Organization Sumitomo Hospital
Division name Department of Anesthesiology
Zip code
Address 5-3-20 Nakanoshima, kita-ku, osaka-shi, Osaka
TEL 06-6443-1261
Email m1294620@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoko Shimizu
Organization Sumitomo Hospital
Division name Department of Anesthesiology
Zip code
Address 5-3-20 Nakanoshima, kita-ku, osaka-city, Osaka, Japan
TEL 06-6443-1261
Homepage URL
Email m1294620@msic.med.osaka-cu.ac.jp

Sponsor
Institute Sumitomo Hospital
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 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
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 Completed
Date of protocol fixation
2017 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 13 Day
Last follow-up date
2017 Year 11 Month 13 Day
Date of closure to data entry
2017 Year 11 Month 13 Day
Date trial data considered complete
2017 Year 11 Month 13 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 10 Day
Last modified on
2017 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030433

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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