UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044524 |
|---|---|
| Receipt number | R000050871 |
| Scientific Title | Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI). |
| Date of disclosure of the study information | 2021/06/14 |
| Last modified on | 2021/06/14 00:48:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI).
Acronym
Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI).
Scientific Title
Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI).
Scientific Title:Acronym
Comparison of one-handde and two-handed mask ventilation after induction of general anesthesia by the Oxygen Reserve Index (ORI).
Region
| Japan |
Condition
Condition
Patient undergoing elective surgery under general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of one-handed and two-handed mask ventilation after induction of general anesthesia by Sp02 and Oxygen Reserve Index(ORI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen Reserve Index 2 minutes after the start of each mask ventilation method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
two minute of one-handed mask ventilation
Interventions/Control_2
two minute of two-handed mask ventilation
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
ASA-PS 1,2
Patients undergoing elective surgery under general anesthesia
Key exclusion criteria
Unexpected difficult airway
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Miyake |
Organization
Japan Self Defense Force Hospital Yokosuka
Division name
Department of Anesthesiology
Zip code
2370071
Address
1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL
046-823-0270
y.miyake0520@gmail.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Miyake |
Organization
Japan Self Defense Force Hospital Yokosuka
Division name
Department of Anesthesiology
Zip code
2370071
Address
1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL
046-823-0270
Homepage URL
y.miyake0520@gmail.com
Sponsor or person
Institute
Japan Self Defense Force Hospital Yokosuka
Institute
Department
Personal name
Funding Source
Organization
Japan Self Defense Force Hospital Yokosuka
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Self Defense Force Hospital Yokosuka
Address
1766-1 Tauraminatocho, Yokosuka, Kanagawa
Tel
046-823-0270
doc33058@ndmc.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
| 2021 | Year | 06 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 14 | Day |
Last modified on
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050871
