Ultrasound Assessment of Gastric Volume in High-Risk Pregnant Women At Term
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe Chaim Sheba Medical Center
About this trial
The risk of pulmonary aspiration of gastric contents remains a significant risk during anesthesia, especially in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician.
This prospective observational study aimed to (1) qualitatively and quantitatively describe the sonographic appearance of the gastric antrum in fasted high-risk pregnant women during the third trimester and (2) evaluate the relationship between demographic and clinical variables and the gastric antral cross-sectional area (CSA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-labouring pregnant women at 3rd trimester (≥ 28 weeks)
18 years or older.
ASA physical status I-III
Hospitilized in High Risk Pregnancy Department
Disqualifiers
Patients with American Society of Anesthesiology (ASA) physical status class IV.
Patient age < 18 years
Pregnant patients with upper gastrointestinal (GI) disease and pathology.
History of upper GI tract surgical procedures.
Trial population
Fasted (6h solids, 2h fluids) high-risk pregnant women at 3rd trimester
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer
Diagnostic testTwo-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Qualitative assessment of the antrum of the stomach
Patients will be classified as follows; Grade 0: the antrum appears empty on both supine and right lateral decubitus positions; grade 1: gastric fluid is visible on the right lateral decubitus position only, suggesting a small fluid volume; and grade 2: gastric fluid is observed in the antrum in both supine and right lateral decubitus, suggesting a larger fluid volume.
Time frame
10 minSecondary outcomes
1
Quantitative assessment of the antrum of the stomach
Three consecutive measures of the CSA (cross sectional area) of the antrum will be calculated via the ultrasound machine (free tracing method).
Time frame
10 minLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: