Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References

Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker

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

Study Overview

• Status: Recruiting
• Conditions: Cardiac Output, Low
• Intervention / Treatment: Device: non-invasive cardiac output monitor

Detailed Description

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

Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings and cardiac output (CO) and stroke volume (SV) measures against thermo-dilution measurements

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Martin C Baruch, PhD; Phone Number: 103 434 978-7000; Email: martin@caretakermedical.net

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Hospital
      • Contact: Irwin Gratz, DO; Phone Number: 856-342-2425; Email: GRATZ-IRWIN@cooperhealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cardiac patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Cardiac patients	Device: non-invasive cardiac output monitor; Equivalence of Caretaker cardiac output reading to reference standard; Other Names: Equivalence of Caretaker cardiac output reading to reference standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output performance comparison	Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.	Change between several paired readings over the course of cardiac surgery (typically 2-4 hours)

Collaborators and Investigators

• Sponsor: CareTaker Medical LLC
• Collaborators: The Cooper Health System

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low
• Other Study ID Numbers: Hemo_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No