Trials / Completed
CompletedNCT04465370
Pediatric Cardiac Output Monitoring Observational Study
A Prospective, Single-Arm, Nonrandomized, Observational Study of Cardiac Output Monitoring in Pediatric Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 89 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-09-02
- Primary completion
- 2023-01-05
- Completion
- 2023-01-05
- First posted
- 2020-07-10
- Last updated
- 2024-11-18
- Results posted
- 2024-11-18
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04465370. Inclusion in this directory is not an endorsement.