N/A
N=89
Pediatric Cardiac Output Monitoring Observational Study
Pediatric ALL
Bottom Line
View on ClinicalTrials.gov: NCT04465370 ↗Enrolled (actual)
89
Serious AEs
5.6%
Results posted
Nov 2024
Primary outcome: Primary: Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output — 0.49 L/min
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bias of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output |
0.49 | — |
| PRIMARY Precision of FloTrac Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output |
1.11 | — |
| PRIMARY Bias of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output |
0.41 | — |
| PRIMARY Precision of ClearSight Arterial Pressure Cardiac Output (L/Min) Against Swan Ganz Invasive Cardiac Output |
1.11 | — |
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)
Data sourced from ClinicalTrials.gov (NCT04465370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.