Clinical trial NCT01980121: Gastric Sonography in the Fasted Term Pregnant Patient for Elective Cesarean Delivery
Official title: Gastric Sonography in the Fasted Term Pregnant Patient for Elective Cesarean Delivery: a Prospective Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Aspiration
Pregnancy
Keywords: Respiratory Aspiration
Pregnancy
Ultrasound
Gastric Contents
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term pregnant patients who have scheduled elective cesearean sections.

Brief summary: 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. In pregnant patients scheduled for elective surgery, standard preoperative guidelines apply as the general non-pregnant surgical population (8-hour fasting of solid food and 2-hour fasting of clear fluids). A bedside ultrasound assessment of the status of the gastric content and volume would be of great value for the clinician. This technique has recently been shown very promising in fasted non-pregnant patients scheduled for elective surgery. Therefore, it is important to study its feasibility in the pregnant population scheduled for elective Cesarean Delivery.

The investigators hypothesize that no residual solid contents will be found in the gastric sonography, and a small volume of gastric fluid will be observed in the antrum in both supine and right lateral decubitus.

Detailed description: The aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted pregnant undergoing elective Cesarean delivery.

The investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective Cesarean delivery after standard preoperative fasting guidelines.

Eligibility criteria: Inclusion Criteria:

* 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: Qualitative assessment of the antrum of the stomach
timeFrame: 10 minutes
Secondary outcomes:
measure: Quantitative assessment of the antrum of the stomach
timeFrame: 10 minutes
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: