Recruiting

Observational Study

Sponsor:

CareTaker Medical LLC

Code:

NCT05035719

Conditions

Cardiac Output, Low

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

non-invasive cardiac output monitor

Study Details

Brief summary:

Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

Conditions

Cardiac Output, Low

Study ID

NCT05035719

Start date

Mar 1, 2021

Status verified date

Aug, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18 years of age
  • able and willing to participate
  • provide written consent

Exclusion Criteria:

  • Unable to give written consent
  • <18 years of age
  • No or poor finger pulse, as determined through visual inspection for ischemic hands

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Cardiac patients

Interventions

non-invasive cardiac output monitor

Equivalence of Caretaker cardiac output reading to reference standard

Primary outcome measure

  • Cardiac output performance comparison [ Time Frame: Change between several paired readings over the course of cardiac surgery (typically 2-4 hours) ]

Central Contacts and Locations

Central contacts

Martin C Baruch, PhD

434 978-7000martin@caretakermedical.net

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Irwin Gratz, DO

856-342-2425GRATZ-IRWIN@cooperhealth.edu

More Information

Sponsor

CareTaker Medical LLC

Last update posted

Sep 5, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CareTaker Medical LLC on 2021-09-05.