Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term

Not Applicable

Completed

• Conditions: Respiratory Aspiration; Pregnancy
• Interventions: Other: water

• Registration Number: NCT01980108
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary

Solid food or fluid residue in the stomach is always a major concern when patients need medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.

The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.

Detailed Description

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. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population.

In this study, patients fast overnight and are randomized to the following groups: empty, or various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their gastric contents are then assessed by an anesthesiologist, using ultrasound. The investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric volume in non-labouring pregnant women.

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: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Volunteer 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: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400mL	water	400mL of water will be given to the patient prior to scanning
50mL	water	50mL of water will be given to the patient prior to scanning
200mL	water	200mL of water will be given to the patient prior to scanning
100mL	water	100mL of water will be given to the patient prior to scanning
300mL	water	300mL of water will be given to the patient prior to scanning

Primary Outcome Measures

Name	Time	Method
Correlation between ingested volume and CSA in antrum	5-10 minutes	The patient will ingest 0, 50, 100, 200, 300 or 400mL of apple juice, and then the cross-sectional area (CSA) will be measured.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada