Clinical trial NCT06803225: Ultrasound Assessment of Gastric Volume in High-Risk Pregnant Women At Term
Official title: ULTRASOUND ASSESSMENT of GASTRIC CONTENT in FASTED PREGNANT WOMEN: PROSPECTIVE OBSERVATIONAL STUDY
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy
Respiratory Aspiration of Gastric Content
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fasted (6h solids, 2h fluids) high-risk pregnant women at 3rd trimester

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Non-labouring pregnant women at 3rd trimester (≥ 28 weeks)
2. 18 years or older.
3. ASA physical status I-III
4. Hospitilized in High Risk Pregnancy Department
5. Ability to understand the rationale of the study assessments and provide signed informed consent.
6. Written informed consent

Exclusion Criteria:

1. Patients with American Society of Anesthesiology (ASA) physical status class IV.
2. Patient age \< 18 years
3. Pregnant patients with upper gastrointestinal (GI) disease and pathology.
4. History of upper GI tract surgical procedures.
5. History of medications that affect gastrointestinal motility.
6. Inability to understand the rationale of the study assessments and provide signed informed consent.

Primary outcomes:
measure: Qualitative assessment of the antrum of the stomach
timeFrame: 10 min
Secondary outcomes:
measure: Quantitative assessment of the antrum of the stomach
timeFrame: 10 min
Other outcomes:
Locations:
Study officials:
References:
citation: Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
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citation: D'Angelo R, Smiley RM, Riley ET, Segal S. Serious complications related to obstetric anesthesia: the serious complication repository project of the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2014 Jun;120(6):1505-12. doi: 10.1097/ALN.0000000000000253.
citation: Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.
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