UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021094 |
|---|---|
| Receipt number | R000024334 |
| Scientific Title | Impact of posture and extracranial contamination on cerebral oximetry by near-infrared spectroscopy |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2016/06/19 10:10:16 |
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Basic information
Public title
Impact of posture and extracranial contamination on cerebral oximetry
by near-infrared spectroscopy
Acronym
Impact of posture and extracranial contamination on cerebral oximetry
by near-infrared spectroscopy
Scientific Title
Impact of posture and extracranial contamination on cerebral oximetry
by near-infrared spectroscopy
Scientific Title:Acronym
Impact of posture and extracranial contamination on cerebral oximetry
by near-infrared spectroscopy
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we investigated the impact of both posture (Trendelenburg position versus upright posture) and extracranial contamination on rSO2 measurements taken by two commercially available devices and one prototype device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The influence of posture and extracranial contamination to rSO2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
They each had three cerebral oximetry devices (FORE-SIGHT ELITETM [CAS Medical Systems, Inc.; Branford, CT], INVOS 5100cTM [Medtronic, Minneapolis, MN, USA], and NIRO-TRS [Hamamatsu Photonics; Hamamatsu, Japan]) applied to the forehead. A circumferential pneumatic head cuff was positioned beneath the NIRS cerebral oximetry sensors. We measured rSO2, heart rate (HR), and blood pressure (BP) in six conditions (supine, head down, and upright posture with and without head cuff inflation) every 5 minutes for each oximetry device. Total hemoglobin (tHb), which is associated with cerebral blood volume (CBV) as measured by positron emission tomography, was measured with the NIRO-TRS device to determine extracranial blood volume in each posture.
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
Healthy volunteers
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Ohnishi |
Organization
Natinal cerebral and cardiovascular center
Division name
Anesthesiology
Zip code
Address
Fujishirodai 5-7-1, Suita, Osaka
TEL
06-6833-5012
yonishi@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Kato |
Organization
National Cerebral and Cardiovascular center
Division name
Anesthesiology
Zip code
Address
Fujishirodai 5-7-1, Suita, Osaka
TEL
06-6833-5012
Homepage URL
numberboy1122@yahoo.co.jp
Sponsor or person
Institute
National cerebral and cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
National cerebral and cardiovascular center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 18 | Day |
Last modified on
| 2016 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024334
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/06/19 | TRS-NIRSの体位による影響 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/06/19 | TRS体位による影響 CRF.docx |
| Research case data | |
|---|---|
| Registered date | File name |
