UMIN-CTR Clinical Trial

Basic information
Public title	The effect of a neurosurgical image guidance system on the performance of two different pulse oximeters
Acronym	Performance of two different pulseoximeters in the environment of neuronavigation
Scientific Title	The effect of a neurosurgical image guidance system on the performance of two different pulse oximeters
Scientific Title:Acronym	Performance of two different pulseoximeters in the environment of neuronavigation
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will clarify to what extent two different pulse oximeters are affected for optical interference by neuronavigation system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference in frequency of interference to two different pulse oximeters by neuronavigation system.
Key secondary outcomes	Difference in signal qality (SQ) Effect of shield using the cover of an alcohol pad

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult
Key exclusion criteria	Hemoglobinopathy Those with abnormality in the SpO2 sensor application site
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kenta Middle name Last name Furutani
Organization	Niigata University Medical and Dental Hospital
Division name	Anesthesiology
Zip code	9497302
Address	Urasa 4132, Minamiuonuma, Niigata, Japan
TEL	025-777-3200
Email	kenta-f@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Furutani
Organization	Niigata University
Division name	Anesthesiology
Zip code	9497302
Address	Urasa 4132, Minamiuonuma, Niigata, Japan
TEL	025-777-3200
Homepage URL
Email	kenta-f@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University Uonuma Kikan Hospital
Institute
Department

Funding Source
Organization	Niigata University Uonuma Kikan Hospital
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	Ethics committee of Uonuma Kikan Hospital
Address	Urasa 4132, Minamiuonuma, Niigata, Japan
Tel	025-777-3200
Email	a-wada@ncmi.or.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	新潟大学地域医療教育センター・魚沼基幹病院

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 18 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	2019 Year 03 Month 05 Day
Date of IRB	2019 Year 03 Month 11 Day
Anticipated trial start date	2019 Year 03 Month 18 Day
Last follow-up date	2019 Year 03 Month 19 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 05 Month 31 Day

Other
Other related information	The incidence of interference for percutaneous oxygen saturation by the neuronavigation system was different between the groups.

Management information
Registered date	2019 Year 03 Month 18 Day
Last modified on	2019 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041108