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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04465370
Other study ID # 2019-08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2, 2020
Est. completion date January 5, 2023

Study information

Verified date October 2023
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution pulmonary artery catheter to the pediatric population 12 to 18 years of age.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date January 5, 2023
Est. primary completion date January 5, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Subjects who are 12 to 18 years of age - Subjects who have signed the Informed Consent Form - Subjects who are projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output measures - For those Subjects who have had a cardiac transplant,Subjects who are at least 2 weeks post cardiac transplantation - Subjects with planned pressure monitoring with an arterial line Exclusion Criteria: - Subjects with contraindications for Pulmonary Artery Catheters Placement and monitoring (recurrent sepsis, or with hypercoagulopathy); - Subjects with contraindications for Arterial Line Placement; - Subjects with an extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand (i.e., Raynaud's Disease). - Subjects with a physical site area too limited for proper Sensor placement - Subjects with finger size less than the smallest finger cuff size - Documented = moderate pulmonary hypertension (PAPm > 25mmHg, PVRI > 3.0 WUxm2) - Presence of intracardiac shunting (i.e., ASD, VSD) - Aorto-pulmonary collaterals - = Moderate tricuspid regurgitation, per echocardiogram criteria - > Moderate Aortic or pulmonary regurgitation, per echocardiogram criteria - Persistent cardiac arrythmias during the cardiac catheterization period (> 3min) - Vascular abnormalities of the arterial system (i.e., connective tissue disorders, mid-aortic syndrome)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan.

Locations

Country Name City State
United States UF Health Shands Children's Hospital Gainesville Florida
United States Texas Children's Hospital Houston Texas
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demonstration of monitoring cardiac output with Swan-Ganz, FloTrac, and ClearSight system Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Bland-Altman method of bias. Duration of the procedure through 30 days after procedure, plus or minus 14 days
Secondary Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Critchley and Critchley method of percent error calculation. Demonstrate that monitoring of cardiac output with Swan-Ganz, FloTrac, and ClearSight system is comparable as determined by the Critchley and Critchley method of percent error calculation. Duration of the procedure through 30 days after procedure, plus or minus 14 days
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