This trial is active, not recruiting.

Condition cardiac event
Treatment retia non-invasive sensors
Sponsor University of Michigan
Collaborator Retia Medical
Start date August 2012
End date October 2015
Trial size 75 participants
Trial identifier NCT01675063, UM HUM 63973


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
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.

Primary Outcomes

Establishment of an auto-calibration algorithm to measure cardiac output
time frame: 8 hours post cardiac surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Development of a Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients
Principal investigator James M Blum, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Michigan.