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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036246
Receipt No. R000041108
Scientific Title The effect of a neurosurgical image guidance system on the performance of two different pulse oximeters
Date of disclosure of the study information 2019/03/18
Last modified on 2019/09/17

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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/ctr_e/ctr_view.cgi?recptno=R000041108

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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