Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework

NCT02588495 | Completed

• 1 other identifier: 14-7883-BE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen. The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.

Conditions

Aspiration

Keywords

Ultrasound; Gastric area; Accuracy; Aspirate

Outcome Measures

Primary Outcomes (1)

• Ultrasound's sensitivity to identify a "full stomach"

  Scanning the stomach to identify if the participant is fasted or has ingested liquid or solids

  5 minutes

Secondary Outcomes (2)

• Ultrasound's accuracy in detecting a "full stomach"

  5 minutes

• Inter/Intra-rater reliability of observer in detecting a "full stomach"

  5 minutes

Study Arms (2)

Fasting

NO INTERVENTION

Participant will remain fasted following initial gastric ultrasound

Food intake

EXPERIMENTAL

Participant will ingest either 250mL of clear fluid (apple juice) or 250mL of coffee and a muffin following initial gastric ultrasound

Other: Food intake

Interventions

Food intake OTHER

Either drinking a cup of clear liquid, or having a cup of coffee and a muffin

Food intake

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers aged 18 to 85 years
• Male or female
• American Society of Anesthesia physical status classification I and II
• Height greater than 145 cm
• Ability to understand the study protocol and provide informed consent

You may not qualify if:

• Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
• History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

• 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.

  PMID: 29624530 DERIVED

MeSH Terms

Interventions

Eating

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Anahi Perlas, MD

  Staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: October 26, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

CA (1)