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

• Sponsor: Augusta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03555604
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related; Aspiration; Airway Aspiration	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 Design

• Study Type: Observational
• Actual Enrollment: 42 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women
• Actual Study Start Date: May 29, 2018
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: Jun 15, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cross sectional area of gastric antrum [10 minutes]

   Cross sectional area of gastric antrum

Secondary Outcome Measures

1. BMI [10 minutes]

   Body mass index

2. Fasting time [8 hours]

   NPO status

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Augusta University	Augusta	Georgia	United States	30912

Sponsors and Collaborators

• Augusta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Efrain Riveros Perez, MD, Assistant Professor Department of Anesthesiology and Perioperative Medicine, Augusta University
• ClinicalTrials.gov Identifier: NCT03555604
• Other Study ID Numbers: 1184342
• First Posted: Jun 13, 2018
• Last Update Posted: Jul 2, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 2, 2019