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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03842527
Enrollment
32
Registered
2019-02-15
Start date
2019-02-11
Completion date
2020-02-28
Last updated
2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

Gastric Ultrasound, Carbohydrate Loading

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.

Interventions

DEVICEUltrasound

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

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Grade 2 antrum1 hour prior to C-section deliveryClear fluid is evident in antrum in both supine and right lateral decubitus scanning positions

Secondary

MeasureTime frameDescription
Incidence of Grade 0 antrum1 hour prior to C-sectionAntrum appears empty in both supine and right lateral decubitus scanning positions
Incidence of Grade 1 antrum1 hour prior to C-sectionAntrum appears empty in supine position, but clear fluid is visible in right lateral decubitus position
Cross-sectional antral area1 hour prior to C-sectionCross-sectional area measurement of the gastric antrum

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026