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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04789785
Other study ID # 182
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 5, 2021
Est. completion date February 20, 2021

Study information

Verified date March 2021
Source Gaziosmanpasa Taksim Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

DETERMINING GASTRIC EMPTYING TIME IN ELDERLY USING ULTRASOUND ASSOCIATED WITH PREOPERATIVE FASTING TIME Background: Gastric contents aspiration is the most crucial complication of general anaesthesia. There are limited studies to assess the gastric volume ultrasound to clarify an appropriate fasting time before surgery. Gastric content will examine after a traditional Turkish breakfast with ultrasound. Methods: After the first ultrasound examination by asking 8 hours fasting ,gastric emptying time(GET) was determined by serial gastric ultrasound examinations with two ultrasonographers and GET identified by real time USG evaluations in every 1 hour. All ultrasound assessments on volunteers will made both in the supine position and right lateral decubitus (RLD) from the epigastric area by using a convex probe. This study is the first one which examine gastric emptying time after a standard Turkish breakfast in over 65 years Turkish population by measuring antral cross section area (CSA) using noninvasive ultrasound.


Description:

Preoperative fasting has always been problematic in preoperative patients because of the pulmonary aspiration hazard and discomfort of prolonged fasting. Although stomach scintigraphy has been accepted as a gold standard for imaging method of evaluating gastric content; recently, ultrasound is being a simple, efficient, available and non invasive alternative. Preoperative fasting is especially difficult in elderly because of comorbidities, dehydration, drug therapies. Therefore, in this study gastric emptying time will be identified after a standard Turkish breakfast in over 65 years old Turkish population to clarify fasting time, measuring antral cross section area (CSA) by using non invasive ultrasound for the first time. Ultrasound assessments on volunteers will be made both in the supine position and right lateral decubitus (RLD) from the epigastric area by using a convex probe. After visualization of gastric antrum according to landmarks such as abdominal aorta, superior mesenteric artery and the left lobe of liver; antrum will measured in two sagittal planes: craniocaudal (CC) and anteroposterior(AP) diameters. Gastric emptying time will be identify by real time usg done by 1 hour intervals.This is the first study with ultrasound evaluation of gastric emptying time in Turkish population after a traditional Turkish breakfast.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date February 20, 2021
Est. primary completion date February 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - over 65 years of age who have not any comorbidities Exclusion Criteria: - gastrointestinal and functional disorders, previous oesophageal or upper abdomen surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ultrasound
observation with usg

Locations

Country Name City State
Turkey Gaziosmanpasa TREH Istanbul Gaziosmanpasa

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labò G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. — View Citation

Soenen S, Rayner CK, Horowitz M, Jones KL. Gastric Emptying in the Elderly. Clin Geriatr Med. 2015 Aug;31(3):339-53. doi: 10.1016/j.cger.2015.04.003. Epub 2015 May 11. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary evaluating gastric emptying time assosiated with preoperative fasting By measuring gastric cross section area using ultrasound to find the emptying time about 6 hours base and real time measurements for 6 hours by 1 hour intervals
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