Gastric Voume Assessment for Aspiration Risk in OB ERAS Patients

Pre-Operative Gastric Volume Assessment Following Carbohydrate-Loading in Obstetrical Patients Undergoing Elective Cesarean Section: A Randomized Clinical Pilot Study

In recent years, human and animal studies have found that carbohydrate-loading prior to surgery leads to improved response to surgical stress and improved postoperative well-being when compared to traditional fasting guidelines. Such positive findings have lead to the increased use of preoperative intake of carbohydrate rich drinks prior to elective surgeries.

However, one of the biggest risks during surgery when a patient is asleep is having stomach contents come up into the lungs. For this reason, a stomach that is empty or has minimal amount of contents is safest. Historically, patients have been instructed not to eat or drink for 8 hours before surgery because it was thought to lower the risk of having fluid or contents in the stomach. This is the current practice patients are asked to follow before undergoing a C-section. However, non-pregnant patients undergoing other surgeries are instructed to have carbohydrate-rich drinks because of the potential benefits. Using ultrasound, the abdomen can be simply scanned to see if there are stomach contents present before surgery. This can allow for the potential determination of what the aspiration risk may be.

What the investigators want to do is look at the safety of using carbohydrate-loading in patients having a C-section. The investigators want to make sure that patients who follow carbohydrate-loading by having a clear, sugary drink 3 hours before a C-section are not at greater risk of having a large amount of stomach contents and be at higher risk of aspirating. This will be done by taking an ultrasound scan of the stomach that will tell the investigators if there are contents in the stomach and whether there is a risk of aspiration.

Patients having an elective C-section will be randomized into two groups. The first group will follow carbohydrate-loading by having a drink of apple juice or cranberry juice cocktail the night before (800mL) and 3 hours before (400mL) the C-section. The second group will follow standard practice of not eating or drinking less than 8 hours prior to surgery. An anesthesiologist will ultrasound the stomach 1 hour before the scheduled procedure time. The first ultrasound will be completed in the supine position (lying on back). The second will be done in the right lateral decubitus position (lying on right side). This should not take more than 5-10 minutes total.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Device: Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Calgary, Alberta, Canada, T1Y 6J4
      • Peter Lougheed Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Non-laboring pregnant women
• ≥36 weeks gestational age
• scheduled elective cesarean delivery
• ≥18 years of age
• ASA physical status I to III
• weight 50 to 120 kg
• height ≥150 cm
• Ability to understand the rationale of the study assessments

Exclusion Criteria:

• multiple gestation
• abnormal anatomy of the upper gastrointestinal tract
• gestational diabetes or pre-existing diabetes mellitus
• previous surgical procedures on the esophagus, stomach, or upper abdomen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Fasting Group; Ultrasound scan of gastric antrum 1 hour prior to procedure. Patients assigned to this group will follow standard fasting procedures of no eating or drinking 8 hours prior to C-section.	Device: Ultrasound; Gastric ultrasound of the stomach antrum to assess contents 1 hour prior to C-section surgery. Scans will be completed in both supine (lying on back) and right lateral decubitus (positions) positions. The completion of both scans will take 5-10 minutes total
Experimental: Carbohydrate Loading Group; Ultrasound scan of gastric antrum 1 hour prior to procedure. Patients assigned to this group must stop eating 8 hours prior to their scheduled C-section time. The night before their C-section they must drink 800mL of 100% apple juice (not from concentrate) OR 800mL of cranberry juice cocktail, not both The day of their C-section, starting 3 hours before surgery and to be finished 2 hours before surgery time, patients must drink 400mL of 100% apple juice OR 400mL of cranberry juice cocktail, not both Please note: The apple juice must be 100% juice, not from concentrate; The cranberry juice cocktail must not be plain cranberry juice	Device: Ultrasound; Gastric ultrasound of the stomach antrum to assess contents 1 hour prior to C-section surgery. Scans will be completed in both supine (lying on back) and right lateral decubitus (positions) positions. The completion of both scans will take 5-10 minutes total

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Grade 2 antrum	Clear fluid is evident in antrum in both supine and right lateral decubitus scanning positions	1 hour prior to C-section delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Grade 0 antrum	Antrum appears empty in both supine and right lateral decubitus scanning positions	1 hour prior to C-section
Incidence of Grade 1 antrum	Antrum appears empty in supine position, but clear fluid is visible in right lateral decubitus position	1 hour prior to C-section
Cross-sectional antral area	Cross-sectional area measurement of the gastric antrum	1 hour prior to C-section

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Gastric Ultrasound; Carbohydrate Loading
• Other Study ID Numbers: REB17-2345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No