Clinical trial NCT01980108: Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term
Official title: Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Aspiration
Pregnancy
Keywords: Pregnancy
Respiratory Aspiration
Gastric Contents
Ultrasound
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between ingested volume and CSA in antrum
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Cristian Arzola, MD
role: PRINCIPAL_INVESTIGATOR
References: