NCT04146233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

28 days

First QC Date

October 29, 2019

Last Update Submit

March 17, 2020

Conditions

Preoperative PeriodAnesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Orange Juice without pulp

OTHER

Drink orange juice without pulp and have gastric ultrasound performed 2 hours later

Other: Point of care gastric ultrasound

Orange juice with pulp

OTHER

Drink orange juice with pulp and have gastric ultrasound performed 2 hours later

Other: Point of care gastric ultrasound

Interventions

Point of care gastric ultrasoundOTHER

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 without pulpOrange juice with pulp

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

  • Christopher Wahal, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Ultrasound images will be saved and reviewed by blinded investigator
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

October 29, 2019

First Posted

October 31, 2019

Study Start

November 19, 2019

Primary Completion

December 17, 2019

Study Completion

December 17, 2019

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)