Point of Care Ultrasound Measurements of Perioperative Edema in Infants With Congenital Heart Disease

NCT04151160 | Completed FDA Device

• 1 other identifier: 19-1387
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease; Edema; Fluid Overload

Keywords

MuscleSound

Outcome Measures

Primary Outcomes (1)

• Ultrasound Measurement of Edema

  Depth (in millimeters) of edema from skin ultrasound measurements.

  Up to Post-Op Day 5

Secondary Outcomes (11)

• Change in Daily Weight

  Day 0, Day 1, Day 2, Day 3, Day 4, Day 5

• Daily Fluid Balance (intake and output)

  Up to Post-Op Day 5

• CVP Measurements

  Up to Post-Op Day 5

• Documentation of edema

  Up to Post-Op Day 5

• Reports of pulmonary edema and/or pleural effusions on chest x-ray reports

  Up to Post-Op Day 5

Study Arms (2)

Case Subjects

Infants with hemodynamically significant congenital heart disease.

Diagnostic Test: Point of care ultrasound measurements

Control Subjects

Healthy infants with no heart disease or non-hemodynamically significant congenital heart disease.

Diagnostic Test: Point of care ultrasound measurements

Interventions

Point of care ultrasound measurements DIAGNOSTIC_TEST

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.

Case Subjects; Control Subjects

Eligibility Criteria

• Age: 0 Days - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Case subjects: Infants with hemodynamically significant congenital heart disease. Control subjects: Healthy infants with no heart disease or non-hemodynamically significant congenital heart disease.

You may qualify if:

• Age less than or equal to 12 months old at the time of enrollment
• Known hemodynamically significant congenital heart disease
• Undergoing surgery, with or without cardiopulmonary bypass, to repair or palliate their congenital heart defect

You may not qualify if:

• Known renal dysfunction
• Prematurity less than 36 weeks corrected gestational age
• Control Subjects:
• Age less than or equal to 12 months old at the time of enrollment
• No known heart disease OR presence of only non-hemodynamically significant congenital heart disease, including: tiny muscular ventricular septal defect, patent foramen ovale, peripheral pulmonary stenosis, normally functioning bicuspid aortic valve (no stenosis and no more than trivial insufficiency), and tiny patent ductus arteriosus
• History of hemodynamically significant congenital heart disease
• History of surgery with general anesthesia
• Known renal dysfunction
• Prematurity less than 36 weeks corrected gestational age

Sponsors & Collaborators

• University of Colorado, Denver: lead
• MuscleSound: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (21)

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  BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Edema

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Persson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Jesse Davidson, MD

  University of Colorado, Denver

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: November 5, 2019
• Study Start: January 13, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)