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

NCT01980121 | Completed

• 1 other identifier: 13-08
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Aspiration; Pregnancy

Keywords

Respiratory Aspiration; Pregnancy; Ultrasound; Gastric Contents

Outcome Measures

Primary Outcomes (1)

• Qualitative assessment of the antrum of the stomach

  Patients will be classified as follows; Grade 0: the antrum appears empty on both supine and right lateral decubitus positions; grade 1: gastric fluid is visible on the right lateral decubitus position only, suggesting a small fluid volume; and grade 2: gastric fluid is observed in the antrum in both supine and right lateral decubitus, suggesting a larger fluid volume.

  10 minutes

Secondary Outcomes (1)

• Quantitative assessment of the antrum of the stomach

  10 minutes

Study Arms (1)

Term pregnant patients

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

Device: Ultrasound

Interventions

Ultrasound DEVICE

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

Term pregnant patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Term pregnant patients who have scheduled elective cesearean sections.

You may qualify if:

• Non-labouring pregnant women at term (≥ 36 weeks)
• years or older
• ASA Physical Status I-III
• kg of weight
• cm of height or taller
• Ability to understand the rationale of the study assessments and to provide signed informed consent
• Written informed consent

You may not qualify if:

• Known pre-existing abnormal anatomy of the upper gastrointestinal tract
• History of upper GI tract surgical procedure

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Cristian Arzola, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 19, 2014

Record last verified: 2014-06

Locations

CA (1)