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

NCT ID: NCT01980121

Last Updated: 2014-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-05-31

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.

Conditions

Respiratory Aspiration; Pregnancy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Term pregnant patients

Term pregnant patients for scheduled elective cesarean section will be examined using a portable ultrasound machine to evaluate gastric contents.

Ultrasound

Intervention Type: DEVICE

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

Interventions

Ultrasound

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristian Arzola, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

13-08

Identifier Type: -

Identifier Source: org_study_id