Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Aspiration; Pregnancy
• Intervention / Treatment: Other: water

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: empty stomach; No fluid will be given to the patient prior to scanning.
Experimental: 50mL; 50mL of water will be given to the patient prior to scanning	Other: water; water
Experimental: 100mL; 100mL of water will be given to the patient prior to scanning	Other: water; water
Experimental: 200mL; 200mL of water will be given to the patient prior to scanning	Other: water; water
Experimental: 300mL; 300mL of water will be given to the patient prior to scanning	Other: water; water
Experimental: 400mL; 400mL of water will be given to the patient prior to scanning	Other: water; water

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Cristian Arzola, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Ultrasound; Pregnancy; Respiratory Aspiration; Gastric Contents
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 13-07