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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04130022
Other study ID # STUDY00000586
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2025

Study information

Verified date February 2024
Source Nationwide Children's Hospital
Contact Catherine Roth
Phone 614-722-2997
Email catherine.roth@nationwidechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility Inclusion Criteria: - ASA 1-2 patients aged 0-18 years of scheduled for elective surgery under general anesthesia. Exclusion Criteria: - Patients who are not adhere to institutional fasting guidelines.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Point-of-Care Ultrasound
Portable ultrasonography done at the bedside.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alok Moharir

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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