Clinical Trials Directory

Trials / Completed

CompletedNCT01980121

Gastric Sonography in the Fasted Term Pregnant Patient for Elective Cesarean Delivery

Gastric Sonography in the Fasted Term Pregnant Patient for Elective Cesarean Delivery: a Prospective Descriptive Study

Status
Completed
Phase
Study type
Observational
Enrollment
103 (actual)
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
Sex
Female
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEUltrasoundTwo-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer

Timeline

Start date
2013-10-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2013-11-08
Last updated
2014-06-19

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01980121. Inclusion in this directory is not an endorsement.