An observational study in Pregnancy and Respiratory Aspiration of Gastric Content, sponsored by The Chaim Sheba Medical Center. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by The Chaim Sheba Medical Center · Observational
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).
The aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted high-risk pregnant women in the 3rd trimester.
The investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective Cesarean delivery after standard preoperative fasting guidelines.
Fasted (6h solids, 2h fluids) high-risk pregnant women at 3rd trimester
Exclusion Criteria:
Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer
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 min
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 min
No study locations are listed for this record.
Plan to share: No — We do not plan to share individual participant data due to a specific request from our institution, which prioritises maintaining the confidentiality and privacy of patient information. The hospital's data-sharing policies and regulatory constraints are designed to safeguard sensitive health data and prevent potential risks of participant re-identification, even after anonymisation.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Respiratory Aspiration of Gastric Contents→
The Chaim Sheba Medical Center