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

• Conditions: Cardiac Output, Low
• Interventions: Device: non-invasive cardiac output monitor

• Registration Number: NCT05035719
• Lead Sponsor: CareTaker Medical LLC

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

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	non-invasive cardiac output monitor	Cardiac patients

Primary Outcome Measures

Name	Time	Method
Cardiac output performance comparison	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.

Trial Locations

Locations (1)

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States