Clinical trial NCT04097236: Body Position and Ultrasound Examination of the Gastric Antrum
Official title: Diagnostic Performance of the Ultrasound Examination of the Antrum to Detect a Full Stomach According to the Position of the Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Aspiration of Gastric Contents
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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))

Primary outcomes:
measure: Calculation of the sensitivity
timeFrame: 3 minutes
Secondary outcomes:
measure: Calculation of the specificity
timeFrame: 3 minutes
measure: Calculation of the positive predictive value,
timeFrame: 3 minutes
measure: Calculation of the negative predictive value
timeFrame: 3 minutes
measure: Calculation of the positive and negative likelihood ratio.
timeFrame: 3 minutes
measure: 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
timeFrame: 3 minutes
measure: 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
timeFrame: 3 minutes
measure: 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
timeFrame: 3 minutes
measure: 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
timeFrame: 3 minutes
measure: 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
timeFrame: 3 minutes
measure: Cut-off value for antral area measured in the supine position (semirecumbent or full supine position) associated with the best diagnostic performance for the detection of a gastric volume ≥1.5 milliliters/kilogram (ml/kg).
timeFrame: 3 minutes
measure: Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
timeFrame: 3 minutes
measure: Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
timeFrame: 3 minutes
measure: Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
timeFrame: 3 minutes
measure: Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
timeFrame: 3 minutes
measure: Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
timeFrame: 3 minutes
measure: Mathematical model for the calculation of the gastric fluid volume
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Sophie Barnoud, Dr
role: PRINCIPAL_INVESTIGATOR
References: