UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043127 |
|---|---|
| Receipt number | R000046961 |
| Scientific Title | Examination of the usefulness of pre-oxygenation techniques in obese patients using oxygenation reserve index |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2025/02/07 14:50:56 |
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Basic information
Public title
Examination of the usefulness of pre-oxygenation techniques in obese patients using oxygenation reserve index
Acronym
Are head-up position and / or positive end expiratory pressure during preoxygenation useful in obese patients?
Scientific Title
Examination of the usefulness of pre-oxygenation techniques in obese patients using oxygenation reserve index
Scientific Title:Acronym
Are head-up position and / or positive end expiratory pressure during preoxygenation useful in obese patients?
Region
| Japan |
Condition
Condition
Patients scheduled for surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the usefulness on head-up position and / or positive end expiratory pressure / pressure support during preoxygenation in obese patients using oxygen reserve index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration from the end of preoxygenation to ORi=0
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
During preoxygenation
1)25 degrees head-up position, PEEP 5-10 cmH2O + PSV 5-10 cmH2O
2)Supine, PEEP 0 cmH2O + PSV 0 cmH2O
Carry out in order of 1 to 2 or b to a for 3 minutes.
Interventions/Control_2
During preoxygenation
1)25 degrees head-up position, PEEP 5-10 cmH2O + PSV 5-10 cmH2O
2)Supine, PEEP 0 cmH2O + PSV 0 cmH2O
Carry out in order of 2 to 1 for 3 minutes.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for surgery under general anesthesia
Body mass index (BMI) 30 kg/m2 or above
Key exclusion criteria
Difficulty airway other than obesity such as facial malformation or genetic disease, serious respiratory and cardiovascular complications, pregnancy, emergency surgery.
Anesthesiologists judged to be inappropriate for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | AYANA |
| Middle name | |
| Last name | KANAYA |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
359-8513
Address
Namiki3-2, Tokorozawa, Saitama
TEL
04-2995-1211
doc31007@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | AYANA |
| Middle name | |
| Last name | KANAYA |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
359-8513
Address
Namiki3-2, Tokorozawa, Saitama
TEL
04-2995-1211
Homepage URL
doc31007@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
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
National Defense Medical College Ethics Committee
Address
Namiki3-2, Tokorozawa, Saitama
Tel
04-2995-1211
ins010@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
防衛医科大学校（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 07 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046961
