Body Position and Ultrasound Examination of the Gastric Antrum

Pulmonary Aspiration of Gastric Contents Clinical Trial

— POSIGAST  

Official title:

Diagnostic Performance of the Ultrasound Examination of the Antrum to Detect a Full Stomach According to the Position of the Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097236
• Other study ID #: 69HCL19_0244
• Secondary ID: 2019-A01333-54
• Status: Completed
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: September 6, 2021

Study information

• Verified date: October 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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))

Related Conditions & MeSH terms

• Pulmonary Aspiration of Gastric Contents
• Respiratory Aspiration of Gastric Contents

Intervention

Other:
• 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).
• 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).

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculation of the sensitivity	Diagnostic performance of the qualitative examination of the gastric antrum in the 45° semirecumbent position.	3 minutes
Secondary	Calculation of the specificity	Diagnostic performance of the qualitative examination of the gastric antrum in full supine/right lateral decubitus position.; The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers.	3 minutes
Secondary	Calculation of the positive predictive value,	Diagnostic performance of the qualitative examination of the gastric antrum in full supine/right lateral decubitus position. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers.	3 minutes
Secondary	Calculation of the negative predictive value	Diagnostic performance of the qualitative examination of the gastric antrum in full supine/right lateral decubitus position. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers.	3 minutes
Secondary	Calculation of the positive and negative likelihood ratio.	Diagnostic performance of the qualitative examination of the gastric antrum in full supine/right lateral decubitus position. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers.	3 minutes
Secondary	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	Calculation of the sensitivity. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	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	Calculation of the specificity The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	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	Calculation of the positive predictive value negative The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	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	Calculation of the negative predictive value. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	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	Calculation of the positive and negative likelihood ratio. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	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).	The cut-off value will be calculated according to the results of the measurements performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation	Calculation of the sensitivity. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation	Calculation of the specificity. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation	Calculation of the positive predictive value. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation	Calculation of the negative predictive value. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation	Calculation of the positive and negative likelihood ratio. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes
Secondary	Mathematical model for the calculation of the gastric fluid volume	Multiple linear regression including the antral surface measured in right lateral decubitus and the age, height, weight of the volunteer. The mathematical model will be built according to the results of the measurements performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers	3 minutes