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Gastric Ultrasound in Pregnant Women at Term

Qualitative Ultrasound Assessment of the Gastric Content of Pregnant Women at Term

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01564030
Enrollment
32
Registered
2012-03-27
Start date
2012-02-29
Completion date
2012-06-30
Last updated
2012-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Aspiration, Pregnancy

Keywords

Pregnancy, Respiratory aspiration, Gastric contents, Ultrasound

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.

Interventions

OTHEREmpty

overnight fast

OTHERFluid

250mL apple juice

OTHERSolid

breakfast

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reliability of the ultrasonographic diagnosis of the gastric status30 minutesThree 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

MeasureTime frame
Inter-observer agreement of gastric content diagnosis30 minutes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026