Gastric Sonography in the Fasted Term Pregnant Patient for Elective Cesarean Delivery

Completed

• Conditions: Respiratory Aspiration; Pregnancy
• Interventions: Device: Ultrasound

• Registration Number: NCT01980121
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary

Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. In pregnant patients scheduled for elective surgery, standard preoperative guidelines apply as the general non-pregnant surgical population (8-hour fasting of solid food and 2-hour fasting of clear fluids). A bedside ultrasound assessment of the status of the gastric content and volume would be of great value for the clinician. This technique has recently been shown very promising in fasted non-pregnant patients scheduled for elective surgery. Therefore, it is important to study its feasibility in the pregnant population scheduled for elective Cesarean Delivery.

The investigators hypothesize that no residual solid contents will be found in the gastric sonography, and a small volume of gastric fluid will be observed in the antrum in both supine and right lateral decubitus.

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 pregnant undergoing elective Cesarean delivery.

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

Inclusion Criteria

• Non-labouring pregnant women at term (≥ 36 weeks)
• 18 years or older
• ASA Physical Status I-III
• 50-120 kg of weight
• 150 cm of height or taller
• Ability to understand the rationale of the study assessments and to provide signed informed consent
• Written informed consent

Exclusion Criteria

• Known pre-existing abnormal anatomy of the upper gastrointestinal tract
• History of upper GI tract surgical procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Term pregnant patients	Ultrasound	Term pregnant patients for scheduled elective cesarean section will be examined using a portable ultrasound machine to evaluate gastric contents.

Primary Outcome Measures

Name	Time	Method
Qualitative assessment of the antrum of the stomach	10 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Quantitative assessment of the antrum of the stomach	10 minutes	Three consecutive measures of the CSA (cross sectional area) of the antrum will be calculated via the ultrasound machine (free tracing method).

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada