UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036246 |
|---|---|
| Receipt number | 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 15:56:31 |
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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
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
kenta-f@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Uonuma Kikan Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041108
