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NCT04465370 · ClinicalTrials.gov registry record

Pediatric Cardiac Output Monitoring Observational Study

A clinical trial, sponsored by Edwards Lifesciences.

Completed
Registry status
89
Enrollment target

NCT04465370: Completed study, sponsored by Edwards Lifesciences.

NCT04465370 is a clinical trial that has completed, run by Edwards Lifesciences. The registered enrollment target is 89 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04465370 has completed, sponsored by Edwards Lifesciences.

COMPLETED
Registry status
89 participants
Enrollment target

Study 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.

Primary Outcome

Bias of FloTrac Arterial Pressure Cardiac Output (APCO) against Swan Ganz Invasive Cardiac Output (ICO) was calculated via Bland-Altman analysis

Interventions

  • DEVICE Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2020-09-02
Est. Completion 2023-01-05
Edwards Lifesciences

57 total trials

What the finished NCT04465370 record still lists

NCT04465370 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 89 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight is the first listed.

NCT04465370 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04465370 about?

NCT04465370 is a clinical study titled "Pediatric Cardiac Output Monitoring Observational Study". 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 o...

What is the current status of trial NCT04465370?

This trial is currently completed. The enrollment target is 89 participants. The study started on 2020-09-02. Estimated completion is 2023-01-05.

What interventions are being tested in trial NCT04465370?

The interventions under investigation include: Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight (DEVICE).

Who is sponsoring clinical trial NCT04465370?

This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04465370, the US trial registry maintained by the National Library of Medicine. NCT04465370 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.