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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980121
• Other study ID #: 13-08
• Status: Completed
• Phase: N/A
• First received: November 4, 2013
• Last updated: June 18, 2014
• Start date: October 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quantitative assessment of the antrum of the stomach	Three consecutive measures of the CSA (cross sectional area) of the antrum will be calculated via the ultrasound machine (free tracing method).	10 minutes	No