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Body Position and Ultrasound Examination of the Gastric Antrum (POSIGAST)

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Civil Hospices of Lyon

Status

Completed

Conditions

Pulmonary Aspiration of Gastric Contents

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04097236
2019-A01333-54 (Other Identifier)
69HCL19_0244

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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))

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

21 participants in 2 patient groups

45° semirecumbent position
Active Comparator group
Treatment:
Other: Qualitative and quantitative assessment of gastric content volume with bed elevation
No elevation of the upper section of the bed
Active Comparator group
Treatment:
Other: Qualitative and quantitative assessment of gastric content volume without bed elevation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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