Clinical trial NCT04789785: Gastric Emptying Time After Turkish Breakfast
Official title: : Determining Gastric Emptying Time In Elderly Using Ultrasound Associated With Preoperative Fasting Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Keywords: gastric content
gastric ultrasonography
preoperative fasting
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-10
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: over 65 years of age Turkish volunteers without comorbity

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* over 65 years of age who have not any comorbidities

Exclusion Criteria:

* gastrointestinal and functional disorders, previous oesophageal or upper abdomen surgery.

Primary outcomes:
measure: evaluating gastric emptying time assosiated with preoperative fasting
timeFrame: base and real time measurements for 6 hours by 1 hour intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa TREH
state: Gaziosmanpaşa
Study officials:
References:
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.
citation: 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.