Change of Gastric Fluid Volume After Oral Hydration in Fasted Objects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Preoperative Fasting

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Jin-Young Hwang, MD,PhD; Phone Number: 82-2-870-2851; Email: mistyblue15@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center
    • Contact: Jin-Young Hwang, MD, PhD; Phone Number: 82-2-870-2518; Email: mistyblue15@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers over 19 years old without a history of abdominal surgery

Description

Inclusion Criteria:

• age ≥19 yrs

Exclusion Criteria:

• history of abdominal surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gastric volume	measure by ultrasound	10 min

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center
• Investigators: Study Chair: Jin-Young Hwang, MD,PhD, SMG-SNU Boramae Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 22, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 10-2023-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No