Minimally Invasive Cardiac Output Monitoring Device

University of Michigan

Status: Completed

Conditions: Cardiac Event

Treatments: Device: Retia Non-Invasive Sensors

Study type: Interventional

Funder types: Other

Identifiers

NCT01675063

UM HUM 63973

Details and patient eligibility

About

The overall goal of this collaborative study is to advance the novel "pulse contour analysis" to the point at which it can be incorporated into a real-time device. The specific objective is to establish an auto-calibration algorithm that conveniently yields cardiac output (CO) in units of liters-per-minute. To achieve this objective, the waveforms for analysis and reference pulmonary artery catheter CO measurements will be recorded from critically ill patients and then analyzed off-line at Retia Medical. Successful completion of this study may ultimately help lead to improved outcomes of critically ill patients.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patients admitted to the University of Michigan ICU following cardiac surgery with both a pulmonary and radial artery catheter.

Exclusion criteria

• Adult patients with mechanical cardiac support including intra-aortic balloon pumps, LVAD, or ECMO, and persistent ventricular arrhythmias.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

Retia Non-Invasive Sensors

Other group

Description:

Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

Treatment:

Device: Retia Non-Invasive Sensors