Reducing Fasting Time in Children

Sponsor

Eunah Cho, MD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05757882

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL	Other: 4 hours of fasting time Other: 2 hours of fasting time	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Comparison of Gastric Ultrasound for Reduction of Fasting Time in Children for Sedation

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 4H Participants who are following the standard fasting time (4 hours).	Other: 4 hours of fasting time Oral intake is not allowed for 4 hours before sedation including water.
Experimental: 2H Participants who are following minimized fasting time (2 hours)	Other: 2 hours of fasting time Oral intake is not allowed for 2 hours before sedation including water.

Arm

Intervention/Treatment

Active Comparator: 4H

Participants who are following the standard fasting time (4 hours).

Other: 4 hours of fasting time

Oral intake is not allowed for 4 hours before sedation including water.

Experimental: 2H

Participants who are following minimized fasting time (2 hours)

Other: 2 hours of fasting time

Oral intake is not allowed for 2 hours before sedation including water.

Outcome Measures

Primary Outcome Measures

Risk of aspiration [10 minutes before sedation]
Gastric antral cross-sectional area assessed with gastric ultrasound

Secondary Outcome Measures

The incidence of Perlas grade 2 [10 minutes before sedation]
Perlas grade 2: fluid appears in both supine and right lateral decubitus positions Perlas grade 1: fluid is detected only in right decubitus position Perlas grade 0: fluid is not detected in both supine and right lateral decubitus positions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Eunah Cho, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eunah Cho, MD, Assistant Professor, Kangbuk Samsung Hospital

ClinicalTrials.gov Identifier:

NCT05757882

Other Study ID Numbers:

NPO1

First Posted:

Mar 7, 2023

Last Update Posted:

Mar 7, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 7, 2023