UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054651 |
|---|---|
| Receipt number | R000062449 |
| Scientific Title | Consideration of mask ventilation method during induction of general anesthesia. -Ventilation setting pressure that does not cause gastric insufflation. - |
| Date of disclosure of the study information | 2024/06/20 |
| Last modified on | 2025/09/03 16:23:12 |
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Basic information
Public title
Consideration of mask ventilation method during induction of general anesthesia. -Ventilation setting pressure that does not cause gastric insufflation. -
Acronym
Consideration of mask ventilation method during induction of general anesthesia. -Ventilation setting pressure that does not cause gastric insufflation. -
Scientific Title
Consideration of mask ventilation method during induction of general anesthesia. -Ventilation setting pressure that does not cause gastric insufflation. -
Scientific Title:Acronym
Consideration of mask ventilation method during induction of general anesthesia. -Ventilation setting pressure that does not cause gastric insufflation. -
Region
| Japan |
Condition
Condition
Patients scheduled for laparoscopic surgery under general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and examine whether gastric insufflation can be prevented by performing mask ventilation at the minimum pressure that keeps oxygenation and hypercapnia within the permissible range during induction of general anesthesia using set pressures of 5cmH20 and 10cmH20.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increased incidence of gastric insufflation detected by ultrasonography of the antrum.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ventilate with a set pressure of 5cmH2O.
Interventions/Control_2
Ventilate with a set pressure of 10cmH2O.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for laparoscopic surgeries under general anesthesia.
Key exclusion criteria
Patients with American Society of Anesthesiologists - Physical Status of 3 or higher, patients under 18 years old, emergency surgery patient, patients after gastrectomy, patients at risk for hypoxemia and gastrosophageal reflex, patients who doesn't agree to test.
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Ayano |
| Middle name | |
| Last name | Tai |
Organization
Toyooka hospital
Division name
Department of Anesthesiology
Zip code
668-8501
Address
1094, Tobera, Toyooka-shi, Hyogo
TEL
0796226111
amssisters@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Tai |
Organization
Toyooka hospital
Division name
Department of Anesthesiology
Zip code
668-8501
Address
1094, Tobera, Toyooka-shi, Hyogo
TEL
0796226111
Homepage URL
amssisters@yahoo.co.jp
Sponsor or person
Institute
Toyooka hospital
Institute
Department
Personal name
Funding Source
Organization
Toyooka hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethics committee of Toyooka hospital
Address
1094, Tobera, Toyooka-shi, Hyogo
Tel
0796226111
amssisters@yahoo.co.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
| 2024 | Year | 06 | Month | 20 | 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
106
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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 03 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062449
