Caretaker Hemodynamic Parameters Validation

Blood Pressure Clinical Trial

Official title:

Caretaker Hemodynamic Parameters Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685733
• Other study ID #: Hemo_001
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2020
• Source: CareTaker Medical LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Specifically, continuous beat-by-beat blood pressure readings against arterial catheter readings, continuous beat-by-beat left ventricular ejection times (LVET) against matching LVETs obtained from central catheters, cardiac output (CO) and stroke volume (SV) measures against thermo-dilution and Fick measurements, and standard HRV parameters based on Caretaker-provided inter-beat intervals (IBI) against the same HRV parameters obtained from ECG-based IBIs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age, who are able and willing to participate and have given written assent

Exclusion Criteria:

• Unable to give written assent

• <18 years of age

• No or poor finger pulse, as determined through visual inspection for ischemic hands

Related Conditions & MeSH terms

• Blood Pressure
• Cardiac Output
• Heart Rate Variability
• Left Ventricular Ejection Time

Intervention

Device:
• Non-invasive hemodynamic measurements
Non-invasive hemodynamic measurements

Locations

Country	Name	City	State
United States	Caretaker Medical	Charlottesville	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
CareTaker Medical LLC	Orange County Research Center, University of Virginia, Yale School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure performance comparison	Comparison with arterial catheter-derived blood pressure, guidelines call for meeting a bias of 5 mmHg and a standard deviation of 8 mmHg	Paired beat-by-beat readings over maximum of 2.5 hours session length
Primary	Cardiac output performance comparison	Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.	Paired measurements over approximately 1 hour time frame
Primary	Left ventricular ejection time comparison	Comparison with LVET derived from central catheter signal traces, agreement within 20 msec.	Paired measurements over approximately 1 hour time frame
Primary	Heart rate variability measures comparison	Comparison with 5 HRV ECG-derived measures, agreement within performance of VitalConnect predicate device	Paired beat-by-beat readings over maximum of 2.5 hours session length