Change of Gastric Fluid Volume After Oral Hydration in Fasted Objects

Preoperative Fasting Clinical Trial

Official title:

Change of Gastric Fluid Volume After Oral Hydration in Fasted Objects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210880
• Other study ID #: 10-2023-32
• Status: Not yet recruiting
• Start date: February 22, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: SMG-SNU Boramae Medical Center
• Contact: Jin-Young Hwang, MD,PhD
• Phone: 82-2-870-2851
• Email: mistyblue15[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• age =19 yrs

Exclusion Criteria:

• history of abdominal surgery

Related Conditions & MeSH terms

• Preoperative Fasting

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastric volume	measure by ultrasound	10 min