Body Position and Ultrasound Examination of the Gastric Antrum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-27

Study Completion Date

2021-09-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Aspiration of Gastric Contents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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45° semirecumbent position

Group Type ACTIVE_COMPARATOR

Qualitative and quantitative assessment of gastric content volume with bed elevation

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Qualitative and quantitative assessment of gastric content volume without bed elevation

Intervention Type 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).

Interventions

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Qualitative and quantitative assessment of gastric content volume with bed elevation

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).

Intervention Type OTHER

Qualitative and quantitative assessment of gastric content volume without bed elevation

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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))

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes