NCT01675063

Minimally Invasive Cardiac Output Monitoring Device

Development of a Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cardiac Event

Interventions

Type	Name	Description
DEVICE	Retia Non-Invasive Sensors	Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-08-29
• Last updated: 2017-05-08
• Results posted: 2017-05-08

Locations

1 site across 1 country: United States