UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034988 |
|---|---|
| Receipt number | R000039901 |
| Scientific Title | Comparison of two ventilation setting during mechanical mask ventilation |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2024/01/26 10:22:36 |
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Basic information
Public title
Comparison of two ventilation setting during mechanical mask ventilation
Acronym
Comparison of two ventilation setting during mechanical mask ventilation
Scientific Title
Comparison of two ventilation setting during mechanical mask ventilation
Scientific Title:Acronym
Comparison of two ventilation setting during mechanical mask ventilation
Region
| Japan |
Condition
Condition
general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare two ventilation setting (pressure control ventilation and pressure control ventilation volume guarantee) during mechanical mask ventilation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of inflow of air into stomach during mechanical mask ventilation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
to use pressure control ventilation - volume guarantee during mechanical mask ventilation
Interventions/Control_2
To use pressure control ventilation during mechanical 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
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who are planned a operation which needs general anesthesia at Tokushima University
Key exclusion criteria
Patients who doesn't agree to test
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Tanaka |
Organization
Tokushima University
Division name
Department of Anesthesiology
Zip code
7708503
Address
Kuramoto Cho, Tokushima City, Tokushima Prefecture
TEL
0886337181
kawanishi.riyosuke@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kawanishi |
Organization
Tokushima University
Division name
Department of Anesthesiology
Zip code
7708503
Address
Kuramoto Cho, Tokushima City, Tokushima Prefecture
TEL
0886337181
Homepage URL
kawanishi.riyosuke@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
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
Clinical Research Review Board of Tokushima University
Address
50-1 2 cho-me, Kuramoto-cho, tokushima-shi, Tokusima-ken, Japan
Tel
0886337958
brinshoshienk@tokushima-u.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
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://tocms.ait231.tokushima-u.ac.jp/tocms/detail.php?id=8481&type=kk
Publication of results
Partially published
Result
URL related to results and publications
https://tocms.ait231.tokushima-u.ac.jp/tocms/detail_houkoku.php?rireki_id=8481&houkoku_id=7306&syous
Number of participants that the trial has enrolled
60
Results
During mechanical mask ventilation, ventilation was maintained at a lower inspiratory pressure with the PCV-VG ventilation volume setting of 8 ml/kg than with the PCV inspiratory pressure of 15 cm H2O.
In addition, PCV-VG had a higher percentage of proper ventilation volume and less gastric gas insufflation.
Results date posted
| 2024 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adults undergoing general anesthesia
Participant flow
After induction of general anesthesia, patients were randomly assigned to be ventilated at PCV inspiratory pressure of 15 cm H2O during mechanical mask ventilation or at PCV-VG ventilation volume setting of 8 ml/kg.
Ventilation volume, inspiratory pressure, and carbon dioxide concentration were measured during mask ventilation.
Adverse events
None
Outcome measures
Inspiratory pressure is lower with PCV-VG.
Adequate ventilation is obtained at a higher rate with PCV-VG.
Gastric gas insufflation is higher with PCV
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039901
