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Clinical Trials/NCT05035719
NCT05035719
Unknown
Not Applicable

Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker

CareTaker Medical LLC1 site in 1 country60 target enrollmentMarch 1, 2021
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ConditionsCardiac Output, Low

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Output, Low
Sponsor
CareTaker Medical LLC
Enrollment
60
Locations
1
Primary Endpoint
Cardiac output performance comparison
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
March 31, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cardiac output performance comparison

Time Frame: Change between several paired readings over the course of cardiac surgery (typically 2-4 hours)

Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.

Study Sites (1)

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