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Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term

Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01980108
Enrollment
60
Registered
2013-11-08
Start date
2013-10-31
Completion date
2016-02-29
Last updated
2016-05-02

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

Conditions

Pregnancy, Respiratory Aspiration

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. 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.

Interventions

OTHERwater

water

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between ingested volume and CSA in antrum5-10 minutesThe patient will ingest 0, 50, 100, 200, 300 or 400mL of apple juice, and then the cross-sectional area (CSA) will be measured.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026