NCT03636828

Brief Summary

Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. Ultrasonography is considering as a useful test assessing the volume of gastric contents, but the emptying time of a rice-based meal (Asian foods) in healthy populations was not clear. The objective of this study was to investigate the minimum fasting time required for adequate gastric emptying after the ingestion of a rice-based meal.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

August 6, 2018

Last Update Submit

November 27, 2018

Conditions

Outcome Measures

Primary Outcomes (7)

  • ultrasonographic measurement of gastric antral cross-sectional area (CSA)

    2 hours after the ingestion of a sold meal

  • ultrasonographic measurement of gastric antral cross-sectional area (CSA)

    3 hours after the ingestion of a sold meal

  • ultrasonographic measurement of gastric antral cross-sectional area (CSA)

    4 hours after the ingestion of a sold meal

  • ultrasonographic measurement of gastric antral cross-sectional area (CSA)

    5 hours after the ingestion of a sold meal

  • ultrasonographic measurement of gastric antral cross-sectional area (CSA)

    6 hours after the ingestion of a sold meal

  • ultrasonographic measurement of gastric antral cross-sectional area (CSA)

    7 hours after the ingestion of a sold meal

  • ultrasonographic measurement of gastric antral cross-sectional area (CSA)

    8 hours after the ingestion of a sold meal

Interventions

Each participant fasted for 10 hours and subjected to a baseline gastric ultrasound and serial sonographic gastric evaluations was performed every hour after 2 hours of the ingestion of a 420 g, 536 Kcal rice-based meal (bibimbap) until the stomach was completely empty.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Study population is 10 healthy volunteers.

You may qualify if:

  • age over 18 years old
  • body mass index between 18.5 and 29.9 kg/m2

You may not qualify if:

  • history of gastrointestinal disease such as history of surgery of upper abdomen, hiatal hernia and gastroesophageal reflux,
  • diabetes mellitus
  • chronic kidney disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

RECRUITING

Study Officials

  • Taejong Song, MD, PhD

    Kangbuk Samsung Hosptial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taejong Song, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 17, 2018

Study Start

October 15, 2018

Primary Completion

December 27, 2018

Study Completion

December 27, 2018

Last Updated

November 29, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations