Gastric Volume Estimation by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Adult

Healthy Participants Clinical Trial

Official title:

The Comparative Gastric Volume Estimation Between Different Time Intervals by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Healthy Adult

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04478435
• Other study ID #: FF-2018-447
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2020
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction; Pre operative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. Gastric antrum is the most amenable and most consistently identified region for sonographic examination during assessment even in empty state. Baseline gastric secretions and clear fluids i.e: water, apple juice and tea have hypoechoeic or anechoic appearance, whilst milk, thick fluids, or suspensions will have increased echogenicity. Evaluation with sonographic assessment were found to be accurately reflective of gastric content in various studies.

In this study, healthy volunteers were recruited. They will be required to fast at least 8 hours prior to baseline gastric antrum ultrasonography assessment. Following that, they will require to drink 250ml glucose loaded drinks. Repeated Ultrasound assessment will be done after 1 hour of glucose loaded drink ingestion in Group 1 and after 2 hours in Group 2. Hypothesis of the study is there will be no significant different between ultrasound assessment between this 2 groups.

Description:

This prospective randomized controlled trial study will be conducted in the Department of Anaesthesiology and Intensive Care UKM for eight months period from November 2018 to June 2019 involving healthy adult volunteers comprising staff members of Department of Anaesthesiology and Intensive Care, after obtaining approval from Research Committee of the Department of Anaesthesiology & Intensive Care, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) and the Medical Research & Ethics Committee, UKMMC. Written informed consent will be obtained from volunteers who fulfill the inclusion criteria.

All volunteers will be fasted, a minimum of 8 hours (duration of fasting will be recorded before the study begin) and will undergo baseline ultrasonographic gastric assessment (t0).

All subjects in Group 1 and group 2 will drink 250 ml of lychee juice (glucose loaded clear fluid containing solution with lychee flavor; 145 kcal in 250 ml) after completion of baseline gastric assessment.

Group 1 subjects will then continue fasting for one hour until completion of second sonographic antral assessment. Subjects in Group 2 will continue fasting for 2 hours until second sonographic antral assessment scan is completed.

Subjects will be divided into 2 groups via computer randomization which will be allocated by anaesthesia trainee that will not be taking part in the analytical and further write up phases of the study. Ultrasonographic volume assessment will be conducted by a single operator who is an anaesthesia Masters trainee, experienced in diagnostic abdominal ultrasound with more than 20 sonographic gastric volume assessments. The images will be recorded and validated by a consultant radiologist.

Ultrasonographic views of antral area will be obtained using a curvilinear array 2- to 5-MHz transducer and a Mindray DC-70 (Shanghai, China) with image compounding technologies. Images will be obtained with the stomach at rest, and between peristaltic contractions. Sonograms of the antral area will be examined in 2 views, cross-section in the supine position, followed by the right lateral decubitus position, at each of the two scanning sessions.

During ultrasonography, the antrum will be imaged in a parasagittal plane in the epigastric area using the left lobe of the liver, the inferior vena cava, and the superior mesenteric vein as internal landmarks. The two vessels are usually visualized slightly to the right of the abdominal midline. Once these vessels were identified, the transducer will be rotated slightly clockwise or counterclockwise to best obtain a true cross-sectional view of the antrum. The anteroposterior and craniocaudal diameters will be measured in this view.

CSA of the antral area (a two-dimensional section) will be calculated according to the formula previously used by Bolondi18 using two maximum perpendicular diameters.

This formula essentially represents the surface area of an ellipse, as follows: CSA (AP x CC x pie/4), where AP is the anteroposterior diameter and CC is the craniocaudal diameter measures in one decimal point.

Estimation of gastric volume will be obtain using this formula:

Predicted gastric volume based on right lateral CSA value : 27 + 14.6 * right lat CSA - 1.28*age (negative volume value indicates and empty state).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: July 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA 1 & 2

Exclusion Criteria:

• Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer

• Prior surgery to upper GI

• On medication that may affect gastric emptying time

• Pregnancy

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Other:
• glucose loaded clear fluid
Ultrasound assessment of gastric antrum is done at different time interval following glucose loaded clear fluid ingestion

Locations

Country	Name	City	State
Malaysia	Pusat Perubatan Universiti Kebangsaan Malaysia	Kuala Lumpur	Wp

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

References & Publications (4)

Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372. — View Citation

Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19. — View Citation

Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. — View Citation

Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline gastric volume	Baseline gastric volume assessed prior to ingestion of glucose loaded clear fluid	Baseline
Primary	Gastric volume assessment	Gastric volume can be calculated with gastric antrum measurement	1 hour after intervention
Primary	Gastric volume assessment	Gastric volume can be calculated with gastric antrum measurement	2 hours after intervention