Caretaker Hemodynamic Parameters Validation

CareTaker Medical

Status: Completed

Conditions: Cardiac Output; Left Ventricular Ejection Time; Heart Rate Variability; Blood Pressure

Treatments: Device: Non-invasive hemodynamic measurements

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04685733

Hemo_001

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

Group 1

Description:

Comparison of blood pressure, LVET and CO/SV measures with respective Gold Standards

Treatment:

Device: Non-invasive hemodynamic measurements

Group 2

Description:

Comparison of blood pressure and HRV measures with respective Gold Standards

Treatment:

Device: Non-invasive hemodynamic measurements

Group 3

Description:

Comparison of blood pressure and CO/SV measures with respective Gold Standards

Treatment:

Device: Non-invasive hemodynamic measurements