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NCT05779683

Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

Completed Last updated 22 March 2023
What this trial tests

trial testing Caretaker Device placement in Cardiac Output in 50 participants. Completed in 28 December 2021.

Timeline
1 November 2021
Primary endpoint
28 December 2021
28 December 2021

Quick facts

Lead sponsorWake Forest University Health Sciences
StatusCompleted
Study typeOBSERVATIONAL
Enrollment50
Start date1 November 2021
Primary completion28 December 2021
Estimated completion28 December 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Cardiac Output or Hemodynamic Monitoring. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Caretaker Device placement

Trials testing the same drug.

Other recruiting trials for Cardiac Output

Currently open trials in the same condition.

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05779683.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing