Gastric Ultrasound in Pregnant Women at Term

Not Applicable

Completed

• Conditions: Respiratory Aspiration; Pregnancy
• Interventions: Other: Empty; Other: Fluid; Other: Solid

• Registration Number: NCT01564030
• 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.

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 fo 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, fluid (250 mL of apple juice before scanning) or solid (full breakfast). Their gastric contents are then assessed by 3 different anesthesiologists, using ultrasound. At the end of the scanning, the true stomach contents are revealed. The ability of the assessors to accurately predict stomach contents, as well as the inter-observer agreement, will be examined.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Volunteer non-laboring pregnant women >32 weeks gestation
• 18 years or older
• ASA status I-III
• Weigh between 50 and 120kg
• Height at least 150cm or taller
• Written informed consent

Exclusion Criteria

• Known pre-existing abnormal anatomy of the upper GI tract
• Protocol violation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empty stomach	Empty	Patients have fasted for 8 hours.
Fluid	Fluid	Patients have fasted for 8 hours, followed by the consumption of 250mL of apple juice.
Solid	Solid	Patients have fasted for 8 hours, followed by the consumption of their breakfast.

Primary Outcome Measures

Name	Time	Method
Reliability of the ultrasonographic diagnosis of the gastric status	30 minutes	Three physicians trained in gastric ultrasound will be blinded to the treatment group the patient was in, perform an ultrasound, and try to guess whether the patient has an empty stomach, consumed fluids only, or consumed a full meal.

Secondary Outcome Measures

Name	Time	Method
Inter-observer agreement of gastric content diagnosis	30 minutes

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada