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

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ClinicalTrials.gov Identifier: NCT04097236
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Pulmonary Aspiration of Gastric Contents Other: Qualitative and quantitative assessment of gastric content volume with bed elevation Other: Qualitative and quantitative assessment of gastric content volume without bed elevation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Diagnostic Performance of the Ultrasound Examination of the Antrum to Detect a Full Stomach According to the Position of the Patient
Estimated Study Start Date : October 2, 2019
Estimated Primary Completion Date : October 9, 2020
Estimated Study Completion Date : October 9, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 45° semirecumbent position 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).

Active Comparator: No elevation of the upper section of the bed 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).




Primary Outcome Measures :
  1. Calculation of the sensitivity [ Time Frame: 3 minutes ]
    Diagnostic performance of the qualitative examination of the gastric antrum in the 45° semirecumbent position.


Secondary Outcome Measures :
  1. Calculation of the specificity [ Time Frame: 3 minutes ]

    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.


  2. Calculation of the positive predictive value, [ Time Frame: 3 minutes ]
    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. Calculation of the negative predictive value [ Time Frame: 3 minutes ]
    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.

  4. Calculation of the positive and negative likelihood ratio. [ Time Frame: 3 minutes ]
    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.

  5. 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 [ Time Frame: 3 minutes ]
    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

  6. 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 [ Time Frame: 3 minutes ]
    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

  7. 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 [ Time Frame: 3 minutes ]
    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

  8. 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 [ Time Frame: 3 minutes ]
    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

  9. 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 [ Time Frame: 3 minutes ]
    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

  10. 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). [ Time Frame: 3 minutes ]
    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

  11. Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation [ Time Frame: 3 minutes ]
    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

  12. Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation [ Time Frame: 3 minutes ]
    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

  13. Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation [ Time Frame: 3 minutes ]
    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

  14. Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation [ Time Frame: 3 minutes ]
    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

  15. Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation [ Time Frame: 3 minutes ]
    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

  16. Mathematical model for the calculation of the gastric fluid volume [ Time Frame: 3 minutes ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097236


Contacts
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Contact: Sophie Barnoud, Dr 4 72 12 97 63 ext 33 sophie.barnoud@chu-lyon.fr

Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sophie Barnoud, Dr Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04097236     History of Changes
Other Study ID Numbers: 69HCL19_0244
2019-A01333-54 ( Other Identifier: ID-RCB )
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration of Gastric Contents
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