UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028478 |
|---|---|
| Receipt number | R000032600 |
| Scientific Title | Comparison between oxygen reserve index and end-tidal concentration during oxygenation via a tight-fitted face mask |
| Date of disclosure of the study information | 2017/08/05 |
| Last modified on | 2022/02/27 10:13:50 |
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Basic information
Public title
Comparison between oxygen reserve index and end-tidal concentration during oxygenation via a tight-fitted face mask
Acronym
Does Oxygen reserve index correlate with end-tidal oxygen concentration?
Scientific Title
Comparison between oxygen reserve index and end-tidal concentration during oxygenation via a tight-fitted face mask
Scientific Title:Acronym
Does Oxygen reserve index correlate with end-tidal oxygen concentration?
Region
| Japan |
Condition
Condition
The cases who receive general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the relationship between Oxygen reserve index and end-tidal oxygen concentration during oxygenation via a tight-fitted face mask.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between oxygen reserve index and end-tidal oxygen concentration
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who receive general anesthesia
ASA-PS(American society of Anesthesiologists -physical status) 1or 2
Key exclusion criteria
The sensor cannot be used due to abnormal fingers.
Anesthesiologists determine that the patient is inappropriate for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Hirata |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
naohirata@mac.com
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Hirata |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
naohirata@mac.com
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
Sapporo Medical University
Address
S1, W16, Chuo-ku, Sapporo, Japan
Tel
011-611-2111
naohirata@mac.com
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
札幌医科大学医学部附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
UMIN000028478
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/ejanaesthesiology/Fulltext/2021/03000/Comparison_between_oxygen_reserve_ind
Number of participants that the trial has enrolled
20
Results
We found that ORi strongly correlates with EtO2 (%) (ORi, F (1, 24.9) = 255.2, P <0.001). When all patients were integrated, EtO2 increased by 17.4 % (95% confidence interval 15.1-19.6 %) with an increase in ORi of 0.1.
Results date posted
| 2022 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
a total of 20 adult patients (20-38 years old), ASA physical status 1 or 2, who underwent minor elective dental surgery (odontectomy and radicular cyst removal), were enrolled.
Participant flow
Patients were preoperatively informed of the entire experimental protocol and gave their written consent for participation.
Adverse events
No patient has any complications.
Outcome measures
The relationship between EtO2 and ORi
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate the clinical efficacy of oxygen reserve index(ORI) during anesthetic induction by comparing ORI with end-tidal oxygen concentration.
Management information
Registered date
| 2017 | Year | 08 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032600
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