Gastric Ultrasound
Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children
1 other identifier
interventional
100
1 country
1
Brief Summary
The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable surgery
Started Jan 2020
Typical duration for not_applicable surgery
1 active site
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 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedStudy Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2022
CompletedResults Posted
Study results publicly available
November 21, 2023
CompletedNovember 21, 2023
February 1, 2023
2.7 years
October 14, 2019
February 9, 2023
February 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Aspiration Risk Grade
Grade 0: No fluid visible in the gastric antrum Grade 1: Clear fluid visualized with volume \< 1.5 mL/kg Grade 2: Clear fluid visualized with volume \> 1.5 mL/kg (High risk of aspiration)
Baseline
Secondary Outcomes (3)
NPO at the Time of Injury
Baseline
NPO at the Time of Surgery
Baseline
Pre-operative Opioid Administration
Baseline
Study Arms (3)
Routine
ACTIVE COMPARATORPatients who are scheduled for routine outpatient surgery.
Urgent
ACTIVE COMPARATORPatients who are scheduled for urgent surgery.
Emergent
ACTIVE COMPARATORPatients who are scheduled for emergency surgery.
Interventions
Eligibility Criteria
You may qualify if:
- ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia.
You may not qualify if:
- History of upper gastro-intestinal surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alok Moharirlead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Results Point of Contact
- Title
- Dr. Alok Moharir
- Organization
- Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Assistant Professor of Anesthesiology
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 15, 2019
Study Start
January 10, 2020
Primary Completion
September 6, 2022
Study Completion
September 6, 2022
Last Updated
November 21, 2023
Results First Posted
November 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share