Gastric Voume Assessment for Aspiration Risk in OB ERAS Patients

NCT ID: NCT03842527

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2020-02-28

Brief Summary

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.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DEVICE

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

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

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Heather Hurdle

Anesthesiologist, Clinical Assistant Professor, Department of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peter Lougheed Centre

Calgary, Alberta, Canada

Foothills Medical Centre

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB17-2345

Identifier Type: -

Identifier Source: org_study_id