UMIN-CTR Clinical Trial

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
Email	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
Email	naohirata@mac.com

Sponsor
Institute	Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032600