UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037013 |
|---|---|
| Receipt number | R000042165 |
| Scientific Title | The assessment of gastric antral cross-sectional area that increase aspiration risk by ultrasonography |
| Date of disclosure of the study information | 2019/06/11 |
| Last modified on | 2024/06/13 16:35:00 |
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Basic information
Public title
The assessment of gastric antral cross-sectional area that increase aspiration risk by ultrasonography
Acronym
The assessment of gastric antral cross-sectional area that increase aspiration risk by ultrasonography
Scientific Title
The assessment of gastric antral cross-sectional area that increase aspiration risk by ultrasonography
Scientific Title:Acronym
The assessment of gastric antral cross-sectional area that increase aspiration risk by ultrasonography
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify the gastric antral cross-sectional area that increase aspiration risk in Japanese
Basic objectives2
Others
Basic objectives -Others
to help to assess preoperative aspiration risk
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gastric antral cross-sectional area after intake 1.5ml/kg water
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA-PS1 or 2
Key exclusion criteria
ASA-PS >2
pregnant women
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Gaku |
| Middle name | |
| Last name | Inagawa |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Anesthesiology
Zip code
240-8555
Address
56, Okazawacho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan
TEL
0453311961
yokohama.city.anesth@gmail.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Goto |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Anesthesiology
Zip code
240-8555
Address
56, Okazawacho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan
TEL
045-331-1961
Homepage URL
yokohama.city.anesth@gmail.com
Sponsor or person
Institute
Yokohama Municipal Citizen's Hospital
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
Yokohama Municipal Citizen's Hospital Ethics Committie
Address
56, Okazawacho, Hodogaya-ku, Yokohama-shi, Kanagawa, 240-8555 Japan
Tel
045-331-1961
by-sh-shomu@city.yokohama.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
横浜市立市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
https://jsa-shoroku.jp/search/detail_program/id:1093
Publication of results
Unpublished
Result
URL related to results and publications
https://jsa-shoroku.jp/search/detail_program/id:1093
Number of participants that the trial has enrolled
10
Results
CSA before and after drinking 1.5 ml/kg of water was 458mm2 and 403mm2 in the supine position, respectively (p=0.79).
In the right lateral position, CSA was 517mm2 and 736mm2, respectively, with an increase in CSA after drinking (p = 0.028).
The cutoff value of CSA measured in the right lateral position after drinking was 672 mm2 (specificity 0.8, sensitivity 0.7), and the AUC was 0.67 (95% confidence interval 0.378-0.962).
Results date posted
| 2024 | Year | 06 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
10 healthy adult volunteers (6 men, 4 women, 1-2 ASA)
Participant flow
The same test is performed on all 10 subjects under the same conditions.
Adverse events
None
Outcome measures
CSA before and after drinking 1.5 ml/kg of water was 458mm2 and 403mm2 in the supine position, respectively (p=0.79).
In the right lateral position, CSA was 517 mm2 and 736 mm2, respectively, with an increase in CSA after drinking (p = 0.028).
The cutoff value of CSA measured in the right lateral position after drinking was 672 mm2 (specificity 0.8, sensitivity 0.7), and the AUC was 0.67 (95% confidence interval 0.378-0.962).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. measuring gastric antral cross-sectional area by ultrasonography after fastened 8 hours and after intake 1.5ml/kg water that is amount seemed to increase aspiration risk
2. to determine between the preoperative aspiration risk and gastric antral cross-sectional area
Management information
Registered date
| 2019 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042165
