Ultrasound Assessment of Gastric Volume in High-Risk Pregnant Women At Term

Sheba Medical Center

Status: Not yet enrolling

Conditions: Respiratory Aspiration of Gastric Content; Pregnancy

Treatments: Diagnostic Test: Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer

Study type: Observational

Funder types: Other

Identifiers

NCT06803225

1346-24-SMC

Details and patient eligibility

About

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).

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.