Clinical trial NCT01564030: Gastric Ultrasound in Pregnant Women at Term
Official title: Qualitative Ultrasound Assessment of the Gastric Content of 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: 2012-03-27
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliability of the ultrasonographic diagnosis of the gastric status
timeFrame: 30 minutes
Secondary outcomes:
measure: Inter-observer agreement of gastric content diagnosis
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arzola C, Cubillos J, Perlas A, Downey K, Carvalho JC. Interrater reliability of qualitative ultrasound assessment of gastric content in the third trimester of pregnancy. Br J Anaesth. 2014 Dec;113(6):1018-23. doi: 10.1093/bja/aeu257. Epub 2014 Jul 30.