NCT05757882CompletedNot Applicable
Comparison of Gastric Ultrasound for Reduction of Fasting Time in Children for Sedation
Eunah Cho, MD1 site in 1 country100 target enrollmentStarted: May 25, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Risk of aspiration
Study Overview
Brief Summary
Patients are asked to be fasted for certain period of time before sedation to reduce the risk of pulmonary aspiration. However, fasting can be harmful, especially in children who has smaller reserves of energy and fluids compared to the adults. Prolonged fasting may increase nausea, vomiting, dehydration, and hypoglycemia. Therefore, it is important to minimize prolonged fasting time in pediatric patients.
This study is aimed to investigate the safety of minimal fasting time (2 hours) compared to the standard fasting time (4 hours) with gastric ultrasound.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pediatric patients aged under 36 months
- •scheduled for elective cardiac echocardiography
Exclusion Criteria
- •patients with disease that delay gastric emptying
- •patients taking medication that delay gastric emptying
- •structural deformities, or abnormalities that interrupt gastric ultrasound
- •refuse to participate in the study
- •sedation is failed or impossible
Outcomes
Primary Outcomes
Risk of aspiration
Time Frame: 10 minutes before sedation
Gastric antral cross-sectional area assessed with gastric ultrasound
Secondary Outcomes
- The incidence of complications(10 minutes after sedation)
Investigators
Eunah Cho, MD
Assistant Professor
Kangbuk Samsung Hospital
Study Sites (1)
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