NCT04130022

Brief Summary

The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication has a small volume.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress59%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

October 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
5.8 years until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

October 14, 2019

Last Update Submit

August 19, 2025

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Change of Qualitative and Quantitative Gastric Assessment After Premedication

    Gastric volume in fasted children before and after drinking premedication. Gastric volume in pediatric patients is estimated by the model: GV= -7.8 + (3.5× RLD CSA) + (0.127) × age (months).

    Ultrasound scan performed at baseline (before surgery) to measure gastric volume and 3 minutes after taking premedication to assess change.

Study Arms (1)

Fasted Children

OTHER
Device: Point-of-Care Ultrasound

Interventions

Point-of-Care UltrasoundDEVICE

Portable ultrasonography done at the bedside.

Fasted Children

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ASA 1-2 patients aged 0-18 years of scheduled for elective surgery under general anesthesia.

You may not qualify if:

  • Patients who are not adhere to institutional fasting guidelines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 17, 2019

Study Start

August 18, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)