Clinical trial NCT04465370: Pediatric Cardiac Output Monitoring Observational Study
Official title: A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Keywords: Hemodynamic Monitoring
Cardiac Output
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 89
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and Females, 12 to 18 years of age at the time of screening. Who presenting to Cardiac Catheterization Lab for right heart catheterizations.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
timeFrame: Duration of cardiac catheterization procedure, an average of 2 hours
measure: Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
timeFrame: Duration of cardiac catheterization procedure, an average of 2 hours
measure: Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
timeFrame: Duration of cardiac catheterization procedure, an average of 2 hours
measure: Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output
timeFrame: Duration of cardiac catheterization procedure, an average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands Children's Hospital
state: Florida
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
References: