Body Position and Ultrasound Examination of the Gastric Antrum

NCT04097236 | Completed

• 2 other identifiers: 69HCL19_02442019-A01333-54
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary aspiration of gastric contents is a complication causing significant morbidity and mortality related to anesthesia. Ultrasound examination of the gastric antrum allows the detection of preoperative gastric contents contributing to the preoperative assessment of pulmonary aspiration risk. In particular, this examination is based on the qualitative analysis of gastric contents performed in the supine and in the right lateral decubitus, using a qualitative score which makes it possible to discriminate a low liquid content of a large liquid volume. This score has been described in patients and volunteers installed on a bed without elevation of the upper section of the bed. However, in several studies, this qualitative score has been achieved in the 45° semirecumbent position, which may have affected the diagnostic performance of the examination thus performed, as suggested by the results of a study recently conducted by the investigating team. This study therefore aims to compare the diagnostic performance of the qualitative analysis of the gastric antrum performed in the supine and the right lateral decubitus for the diagnosis of gastric volumes higher than 50 ml and 100 ml, according to the bed angle: 45 ° elevation or no elevation of the upper section of the bed.

Conditions

Pulmonary Aspiration of Gastric Contents

Outcome Measures

Primary Outcomes (1)

• Calculation of the sensitivity

  Diagnostic performance of the qualitative examination of the gastric antrum in the 45° semirecumbent position.

  3 minutes

Secondary Outcomes (16)

• Calculation of the specificity

  3 minutes

• Calculation of the positive predictive value,

  3 minutes

• Calculation of the negative predictive value

  3 minutes

• Calculation of the positive and negative likelihood ratio.

  3 minutes

• Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position

  3 minutes

Study Arms (2)

45° semirecumbent position

ACTIVE COMPARATOR

Other: Qualitative and quantitative assessment of gastric content volume with bed elevation

No elevation of the upper section of the bed

ACTIVE COMPARATOR

Other: Qualitative and quantitative assessment of gastric content volume without bed elevation

Interventions

Qualitative and quantitative assessment of gastric content volume with bed elevation OTHER

Ultrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session).

45° semirecumbent position

Qualitative and quantitative assessment of gastric content volume without bed elevation OTHER

Ultrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session).

No elevation of the upper section of the bed

Eligibility Criteria

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

You may qualify if:

• Adults 18 years old or older
• Last consumption of solids at least 6 hours before the start of the study, last consumption of clear fluids at least 2 hours before the start of the study
• Informed consent must have been signed.
• No significant medical history (American Society of Anesthesiologists (ASA) class 1)

You may not qualify if:

• Adult unable to give informed consent
• Previous gastrointestinal surgery
• Medication affecting gastric motility
• Digestive diseases, gastroparesis, diabetes mellitus with insulin
• Pregnancy or breastfeeding
• Obesity (Body Mass Index (BMI) ≥ 30 kilograms/meter² (kg/m²))

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

Related Publications (1)

• Bouvet L, Cordoval J, Barnoud S, Berlier J, Desgranges FP, Chassard D. Diagnostic performance of qualitative ultrasound assessment for the interpretation of point-of-care gastric ultrasound to detect high gastric fluid volume: A prospective randomized crossover study. J Clin Anesth. 2022 Oct;81:110919. doi: 10.1016/j.jclinane.2022.110919. Epub 2022 Jul 2.

  PMID: 35792453 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie Barnoud, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: September 20, 2019
• Study Start: November 27, 2019
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

FR (1)