- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564030
Gastric Ultrasound in Pregnant Women at Term
Qualitative Ultrasound Assessment of the Gastric Content of Pregnant Women at Term
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Empty stomach
Patients have fasted for 8 hours.
|
overnight fast
|
Other: Fluid
Patients have fasted for 8 hours, followed by the consumption of 250mL of apple juice.
|
250mL apple juice
|
Other: Solid
Patients have fasted for 8 hours, followed by the consumption of their breakfast.
|
breakfast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability of the ultrasonographic diagnosis of the gastric status
Time Frame: 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.
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inter-observer agreement of gastric content diagnosis
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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