Change of Gastric Fluid Volume After Oral Hydration in Fasted Objects

NCT ID: NCT06210880

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-22

Study Completion Date

2025-12-31

Brief Summary

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This study aims to evaluate the permissive amount and time limit of clear fluid intake for preoperative fasting.

Detailed Description

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Observations of two kinds of liquids (water, carbohydrate drink) in five different volumes (10ml, 50ml, 100ml, 200ml, 400ml) will be performed on different days. Subjects prepare for investigation, a 4-hour fast excluding water, followed by 1 hour of fasting including water, and then 10 ml or 50 ml or 100 ml or 200 ml or 400 ml of clear water in a pre-randomized order and then the cross-sectional area of the stomach antrum will be measured via ultrasound every 10-minute until the contents are no longer visible. The same observation will be performed with a noNPO drink beverage containing 50 g of carbohydrate, again in a randomized order, and then 10 ml, 50 ml, 100 ml, 200 ml or 400 ml, and then every 10 minutes until the contents are no longer visible. One dose of one type of fluid will be ingested and observed at each visit, and repeated visits will be made until observations for all doses have been completed (10 visits in total, with 5 doses of water and carbohydrate drinks). During measurement, the stomach will be checked for contents supine position and then turned to the right decubitus.

Conditions

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Preoperative Fasting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age ≥19 yrs

Exclusion Criteria

* history of abdominal surgery
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin-Young Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Young Hwang, MD,PhD

Role: STUDY_CHAIR

SMG-SNU Boramae Medical Center

Locations

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SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Jin-Young Hwang, MD,PhD

Role: CONTACT

82-2-870-2851

Facility Contacts

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Jin-Young Hwang, MD, PhD

Role: primary

82-2-870-2518

References

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Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.

Reference Type BACKGROUND
PMID: 8424572 (View on PubMed)

Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.

Reference Type BACKGROUND
PMID: 17122571 (View on PubMed)

Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.

Reference Type BACKGROUND
PMID: 16563326 (View on PubMed)

Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labo G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. doi: 10.1016/0016-5085(85)90569-4.

Reference Type BACKGROUND
PMID: 3896910 (View on PubMed)

Milling TJ Jr, Rose J, Briggs WM, Birkhahn R, Gaeta TJ, Bove JJ, Melniker LA. Randomized, controlled clinical trial of point-of-care limited ultrasonography assistance of central venous cannulation: the Third Sonography Outcomes Assessment Program (SOAP-3) Trial. Crit Care Med. 2005 Aug;33(8):1764-9. doi: 10.1097/01.ccm.0000171533.92856.e5.

Reference Type BACKGROUND
PMID: 16096454 (View on PubMed)

Other Identifiers

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10-2023-32

Identifier Type: -

Identifier Source: org_study_id

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