CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Point of care ultrasound measurementsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04151160
NCT04151160N/ACompleted

Using Point of Care Ultrasound to Measure Perioperative Edema in Infants With Congenital Heart Disease

University of Colorado, Denver·observational·Posted Nov 5, 2019·Updated May 10, 2023

In Brief

An observational study evaluating Point of care ultrasound measurements for Congenital Heart Disease and 2 related conditions. Completed, enrolled 72 participants across 1 site.

Detailed Summary

Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in babies, so it can be hard to know how much diuretic they need to treat the swelling. The investigators are looking for a better way to measure swelling in babies who have had heart surgery. Ultrasound uses sound waves to take pictures of the inside of the body. Ultrasound is used to take pictures of babies before they are born and to take pictures of their heart after they are born. New ultrasound software has been made from a company called MuscleSound that can quickly measure the amount of swelling in adults, usually in less than 2 minutes. This software has not yet been used to measure swelling in kids. This study plans to learn more about swelling in babies and will try to measure swelling in babies before and after heart surgery with the new ultrasound software. The study will also make the same measurements in babies who do not have heart disease to compare to babies having heart surgery.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMuscleSound

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 5, 2019
Enrollment StartJan 13, 2020
Primary CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.7 years ago

Interventions

Point of care ultrasound measurementsother

i. Ultrasound images will be obtained using a commercial, high frequency, linear Philips ultrasound probe attached to small, portable tablet. This tablet will have the capability of transferring the saved images to the secure MuscleSound cloud-based server.