UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020265 |
|---|---|
| Receipt number | R000023395 |
| Scientific Title | Observational study of gastric emptying of solid meal assessed by abdominal ultrasound |
| Date of disclosure of the study information | 2015/12/19 |
| Last modified on | 2016/08/30 18:43:39 |
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Basic information
Public title
Observational study of gastric emptying of solid meal assessed by abdominal ultrasound
Acronym
gastric emptying of solid meal assessed by abdominal ultrasound
Scientific Title
Observational study of gastric emptying of solid meal assessed by abdominal ultrasound
Scientific Title:Acronym
gastric emptying of solid meal assessed by abdominal ultrasound
Region
| Japan |
Condition
Condition
Adult patients scheduled for elective ophthalmologic surgery under local anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore gastric emptying time of solid meal
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cross sectional area of antrum measured by abdominal ultrasound
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled for elective opthalamologic surgery under local anesthesia
2) Patients who have morning meal and have afternoon surgery
Key exclusion criteria
1) Patients who can not abide fasting
2) Patients with stomach obstruction
3) Patients with oral ingestion impossible
4) Patients who have past history of aspiration pneumonia
5) Pregnant women
6) Patients with possible sedation
7) Patients can not cooperate ultrasound assessment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiroh Isono |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Anesthesiology
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL
043222-7171
shirohisono@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiroh Isono |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Anesthesiology
Zip code
Address
Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Scholarship donation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 12 | Month | 19 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 08 | Month | 30 | Day |
Other
Other related information
This is a prospective Cohort study exploring gastric emptying time determined by residual gastric contents and fasting time in patients scheduled for elective opthalamologic surgery under local anesthesia.
Patients is asked to fast solid meal after morning meal, but allows to drink clear fluid until 2 hours before operation. Immediately before the operation, abdominal ultrasound is performed to measure cross sectional area of antrum in the lateral position.
Subgroup analyses are planned for patients with diabetes mellitus and for patients over 80 years old.
Management information
Registered date
| 2015 | Year | 12 | Month | 18 | Day |
Last modified on
| 2016 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023395
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
