NCT05035719

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

Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: CareTaker Medical LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Cardiac Output, Low

Interventions

Type	Name	Description
DEVICE	non-invasive cardiac output monitor	Equivalence of Caretaker cardiac output reading to reference standard

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-09-05
• Last updated: 2021-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study