UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029059 |
|---|---|
| Receipt number | R000033236 |
| Scientific Title | A comparison of cerebral oxygenation as measured by the O3, the NIRO 200 and the INVOS 5100 Near-Infrared Spectrophotometers |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2023/02/08 14:47:33 |
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Basic information
Public title
A comparison of cerebral oxygenation as measured by the O3, the NIRO 200 and the INVOS 5100 Near-Infrared Spectrophotometers
Acronym
A comparison of cerebral oxygenation as measured by the O3, the NIRO 200 and the INVOS 5100 Near-Infrared Spectrophotometers
Scientific Title
A comparison of cerebral oxygenation as measured by the O3, the NIRO 200 and the INVOS 5100 Near-Infrared Spectrophotometers
Scientific Title:Acronym
A comparison of cerebral oxygenation as measured by the O3, the NIRO 200 and the INVOS 5100 Near-Infrared Spectrophotometers
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate accuracy and usability of Mashimo O3, comparing with INVOS5100C and NIRO-200NX with healthy volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing with values of regional oxygen saturation(rSO2) measured by three devices
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
position with head up and head down, oxygenation, and hyperventilation
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy volunteers
Key exclusion criteria
disease of respiratory, heart or central nervous system
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kaneyuki |
| Middle name | |
| Last name | Kawamae |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2, Iida-nishi, Yamagata-shi, Yamagata
TEL
023-628-5400
kkawamae@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Suzuki |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2, Iida-nishi, Yamagata-shi, Yamagata
TEL
023-628-5400
Homepage URL
yoreyore0@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Yamagata University
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
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2, Iida-nishi, Yamagata city, Yamagata, Japan
Tel
023-628-5047
ikekenkyu@jm.kj.yamagata-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.aub.edu.lb/fm/Anesthesiology/meja/Documents2/Volume28/MEJA%20No%2028%202021.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.aub.edu.lb/fm/Anesthesiology/meja/Documents2/Volume28/MEJA%20No%2028%202021.pdf
Number of participants that the trial has enrolled
9
Results
The differences in baseline mean rScO2 of MASIMO O3 compared to NIRO 300 and INVOS 5100 were significantly lower (p < 0.05).
The estimates for both absolute-agreementand consistency tests for NIRO 300 and INVOS 5100 pairs were 0.74.
The estimates for NIRO 300 and MASIMO O3 pair for absolute agreement was 0.43. Estimates for INVOS 5100 and MASIMO O3 were similar to those for NIRO 300 and MASIMO O3 (absolute agreement = 0.48).
Results date posted
| 2023 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean (SD) age was 27 (2) years with a range of 25 - 30 years.
The mean (SD) weight and height were 64 (10) kg and 167 (10) cm respectively, while the body mass index (BMI) ranged from 19.4 to 26.0 kg/m2 with a mean (SD) 22.5 (2.5) kg/m2.
Participant flow
With the volunteers in supine position on the operating room (OR) table, the adhesive optodes of NIRO, INVOS, and MASIMO O3 were placed sequentially one after the other on the left side of the forehead 1cm above the eyebrow and 1cm lateral to the midline. The study had 7 sequential stages with each lasting 5 minutes, followed by a 3 minute period for equilibration before the next stage (Figure 1). Each volunteer went through each of the 7 stages for each of the sensors in a sequence ofNIRO to INVOS to MASIMO. A transition period of 5 minutes for change of sensor to the next NIRS monitor was observed.
Each volunteer went through a total of 21 stages. The volunteers were instructed to
breathe normally in room air (Control-A), then 20 degrees head down, 20 degrees head up, then supine with the volunteers breathing hyperoxic gas mixtures with fraction of inspired oxygen (FiO2) of 45% followed by FiO2 of 100% administered via Drager anesthesia machine. Volunteers were returned to room air in supine position (Control-B) before they were finally instructed to hyperventilate in room air until an ETCO2 value of 22.5mmHg (3.0 kPa) was achieved for the hyperventilation stage. The angle of the OR table was standardised using a digital angle meter. Oxygen analyzer on the anaesthesia machine was used to ensure delivery of the desired oxygen concentration.
Gas delivery was through a single use disposable circle breathing system attached to a properly fitting mask.
Main streaming ETCO2 unit was connected between the HME filter and the Y-piece of the breathing system.
For each of the interventions, vital parameters were recorded over the 5 minute period.
Adverse events
nothing
Outcome measures
Data collected from each of the subjects after proper medical history for exclusion of inappropriate volunteers included demographic data (age, weight, height).
The heart rate (HR), peripheral oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), stroke volume (SV), cardiac Index (CI) and regional cerebral oxygen
saturation (rScO2) were measured continuously after obtaining baseline values. Recordings were manually extracted and entered into the study proforma at intervals of 1 min throughout the study period.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033236
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