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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146233
Recruitment Status : Completed
First Posted : October 31, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher Wahal, Thomas Jefferson University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preoperative Period Anesthesia Other: Point of care gastric ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Ultrasound images will be saved and reviewed by blinded investigator
Primary Purpose: Diagnostic
Official Title: An Observer Blinded Point-of-care Gastric Ultrasound Analysis of the Gastric Emptying Time of Orange Juice With and Without Pulp
Actual Study Start Date : November 19, 2019
Actual Primary Completion Date : December 17, 2019
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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).

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).




Primary Outcome Measures :
  1. Assessment of Gastric Volume at 2 hours [ Time Frame: 2 hours after intervention ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146233


Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Christopher Wahal, MD Thomas Jefferson University
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Responsible Party: Christopher Wahal, Assistant Professor of Anesthesiology, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04146233    
Other Study ID Numbers: 19D.577
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No