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NCT05779683 · ClinicalTrials.gov registry record

Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

A clinical trial of Cardiac Output and Hemodynamic Monitoring, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
50
Enrollment target
1
Study location

NCT05779683: Completed study of Cardiac Output and Hemodynamic Monitoring, sponsored by Wake Forest University Health Sciences.

NCT05779683 is a study of Cardiac Output and Hemodynamic Monitoring that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 50 participants, roughly in line with the 49-participant average among 4 other Cardiac Output trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05779683, a study of Cardiac Output and Hemodynamic Monitoring, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
50 participants
Enrollment target
1
Study location

Study Summary

To monitor the cardiac post-op patient population with both the pulmonary artery catheter (PAC) and the Caretaker monitor, which will seek to validate the Caretaker monitor against continuous CO via the PAC. Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as atrial flutter and atrial fibrillation. Secondary analysis will be performed on the collected data to assess the Caretaker monitor's agreement with the PAC during periods of arrhythmia. Successful completion this study will provide clinical validation of the Caretaker monitor in one of the most hemodynamically challenging patient populations (post-cardiac surgery patients in the ICU), including during arrhythmias. The Caretaker monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject. This device also does not project energy into the subject.

Primary Outcome

To assess the agreement of the Caretaker monitor CO with the thermodilution method using the swan-ganz or pulmonary artery (PAC) catheter in critically ill cardiac surgery post-op ICU patients.

Interventions

  • DEVICE Caretaker Device placement

Study Locations (1)

North Carolina

  • Atrium Health Wake Forest Baptist - Winston-Salem

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-11-01
Est. Completion 2021-12-28
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT05779683 record still lists

NCT05779683 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 49-participant average among 4 other Cardiac Output trials with a reported enrollment target.

The record links to 2 conditions, with Cardiac Output appearing as the primary indexed condition, and to 1 intervention - of which Caretaker Device placement is the first listed.

NCT05779683 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT05779683 about?

NCT05779683 is a clinical study titled "Caretaker in the Cardiovascular Intensive Care Unit (CVICU)". To monitor the cardiac post-op patient population with both the pulmonary artery catheter (PAC) and the Caretaker monitor, which will seek to validate the Caretaker monitor against continuous CO via the PAC. Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as...

What is the current status of trial NCT05779683?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2021-11-01. Estimated completion is 2021-12-28.

What conditions does trial NCT05779683 study?

This clinical trial studies the following conditions: Cardiac Output, Hemodynamic Monitoring.

What interventions are being tested in trial NCT05779683?

The interventions under investigation include: Caretaker Device placement (DEVICE).

Who is sponsoring clinical trial NCT05779683?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05779683 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05779683, the US trial registry maintained by the National Library of Medicine. NCT05779683 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.