Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women

This study seeks to determine if a relationship exists between gastric antrum cross-sectional area measured using ultrasound and BMI in term pregnant women (>37 weeks gestation).

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Airway Aspiration; Aspiration
• Intervention / Treatment: Diagnostic test: Gastric ultrasound

Detailed Description

After approval by the Institutional Review Board, the investigators will obtain consent from patients. The consent will be obtained by the authorized personnel as per protocol, in which the investigators will explain to the patient the procedure, benefit, risk, cost and, confidentiality. The investigators plan to get the consent immediately after the patient arrived at the unit to avoid any interference with the delivery process. If the patient needs to go to an emergency cesarean section. This patient is not going to be included in the study. A gastric ultrasound with a low frequency (1-5 Hz) curvilinear array transducer using a Philips (CX-50) (Bothell, WA. USA) with image compounding technology, will be performed in each patient. The ultrasound procedure will be performed in the supine position and in a semi-recumbent right lateral position. The antrum will be identified in the sagittal plane between the liver, pancreas and aorta between peristaltic contractions. The ultrasound will be performed in each patient, in each position by three operators: two staff anesthesiologists and an anesthesia resident in presence of a medical student who will make sure that the standards for the procedure are uniform between operators (three images will be recorded by each operator per position in each patient). A qualitative assessment will be initially made, consisting of three grades: Grade 0, no fluid evidenced; Grade 2, clear fluid is evidenced only in right lateral decubitus position, and Grade 3, fluid is evidenced in both positions. Quantitative measurement of the cross-sectional area of the antrum (CSA) will be done by means of free tracing calipers. The full-thickness of the gastric wall will be included in the measurement and the average from the three images of each operator will be recorded. CSA will be calculated using the following formula:

CSA =(π x mean anteroposterior diameter x mean longitudinal diameter)/4

In addition to qualitative and quantitative ultrasound measures, the investigators will record demographic variables including age, BMI, weeks of gestation, gravity and parity.

The investigators plan to evaluate the existence of a relationship between cross-sectional area of the antrum (CSA) and BMI in term pregnant women using measurements of the CSA taken with free tracing calipers in ultrasound

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Term pregnant patients scheduled for cesarean section, who meet inclusion criteria

Description

Inclusion Criteria:

1. Pregnant patients >37 weeks of gestation
2. Age older than 18 years
3. NPO status >6 hours

Exclusion Criteria:

1. Unwillingness to participate in the study
2. Diagnosis of upper gastrointestinal disease
3. Episode of vomiting within the last 6 hours
4. Patients taking gastric pro-kinetic medications
5. Diabetes mellitus
6. Prior gastric, esophageal or upper abdominal surgery
7. Allergy to US gel

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Scheduled cesarean section; Gastric ultrasound in term pregnant patients to correlate with NPO time in relation to body mass index	Diagnostic test: Gastric ultrasound; Gastric ultrasound to measure antrum cross sectional area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cross sectional area of gastric antrum	Cross sectional area of gastric antrum	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Body mass index	10 minutes
Fasting time	NPO status	8 hours

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1184342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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