POCUS Analysis of the Gastric Emptying Time of Orange Juice With and Without Pulp

An Observer Blinded Point-of-care Gastric Ultrasound Analysis of the Gastric Emptying Time of Orange Juice With and Without Pulp

Preoperative fasting guidelines for anesthesia recommend waiting two hours after ingesting a clear liquid and six hours after ingesting a light meal. Due to the presence of pulp, orange juice is considered a light meal by current guidelines which means a patient must wait six hours before undergoing general anesthesia. This study will use ultrasound of stomach of healthy volunteers to determine if the presence of pulp actually increases the transit time for orange juice.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Preoperative Period
• Intervention / Treatment: Other: Point of care gastric ultrasound

Detailed Description

Healthy volunteers will be solicited (medical students and attending anesthesiologists) to participate in the study. Volunteers will participate in two sessions, one for orange juice without pulp and one for orange juice with pulp. Participants will be NPO after midnight and will be asked to arrive at approximately 8 am. Upon arrival for females of child bearing age, a urine pregnancy test will be performed and they will be discreetly informed of the results of the test. After, all patients will have their gastric volume assessed using point-of-care ultrasound to ensure the study team is able to adequately identify their stomach as well as to ensure the stomach is empty. After measurements are made, participants will drink 12 oz (approximately 350 mL) of either orange juice with or without pulp. Two hours after finishing the juice they will again undergo point-of-care gastric ultrasound scanning. Images will be saved and will be examined by a blinded independent anesthesiologist. The study will entail two visits each lasting for approximately 3 hours.

Point-of-care gastric ultrasound will be performed using a low-frequency curvilinear ultrasound probe. The exam will be performed on a stretcher with the participant in both the supine and right lateral decubitus (RLD) position. The goal of point-of-care gastric ultrasound is to obtain an image of the gastric antrum. The low-frequency large curvilinear probe is placed in the epigastric area in a sagittal or parasagittal plane immediately inferior to the patient's xiphisternum with the orientation marker directed cephalad. Image optimization requires scanning in an anterior and cephalad direction toward the liver by tilting the tail of the probe toward the feet. A qualitative analysis will occur first to rule out solid contents in the stomach. Once confirmed, the gastric antral cross-sectional area (CSA) will be measured in the RLD position. Correlation has been shown between CSA and total gastric fluid volume. A gastric volume less than 1.5 mL/kg is considered consistent with fasting.

The study will be repeated for both orange juice with and without pulp.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• volunteers age 18-65 years old, American Society of Anesthesiologists physical status 1-2

Exclusion Criteria:

• presence of diabetes mellitus, previous gastric surgery, presence of hiatal hernia, history of delayed gastric emptying, pregnant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Orange Juice without pulp; Drink orange juice without pulp and have gastric ultrasound performed 2 hours later	Other: Point of care gastric ultrasound; Point-of-care gastric ultrasound will be performed using a low-frequency curvilinear ultrasound probe to assess stomach contents (empty vs. not empty, liquid vs. solid, gastric volume).
Other: Orange juice with pulp; Drink orange juice with pulp and have gastric ultrasound performed 2 hours later	Other: Point of care gastric ultrasound; Point-of-care gastric ultrasound will be performed using a low-frequency curvilinear ultrasound probe to assess stomach contents (empty vs. not empty, liquid vs. solid, gastric volume).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Gastric Volume at 2 hours	Two hours after orange juice (with and without pulp) is consumed, point of care gastric ultrasound will be used to assess gastric contents and gastric volume	2 hours after intervention

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Christopher Wahal, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): December 17, 2019
• Study Completion (Actual): December 17, 2019

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 19D.577

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