UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of head-down position on fingertip and forehead pulse oximetry
Title of the study (Brief title)	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	Motoko Shimizu
Organization	Sumitomo Hospital
Division name	Department of Anesthesiology
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	Motoko Shimizu
Organization	Sumitomo Hospital
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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