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NCT05035719 Clinical Trial

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

Cardiac Output, Low Clinical Trial

Official title:
Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05035719
Other study ID # Hemo_002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date March 31, 2022

Study information
Verified date August 2021
Source CareTaker Medical LLC
Contact Martin C Baruch, PhD
Phone 434 978-7000
Email martin@caretakermedical.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• non-invasive cardiac output monitor
Equivalence of Caretaker cardiac output reading to reference standard

Locations
Country Name City State
United States Cooper University Hospital Camden New Jersey

Sponsors (2)
Lead Sponsor Collaborator
CareTaker Medical LLC The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
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