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Minimally Invasive Cardiac Output Monitoring Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01675063
Recruitment Status : Completed
First Posted : August 29, 2012
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Retia Medical
Information provided by (Responsible Party):
Dr. James M. Blum, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Event Device: Retia Non-Invasive Sensors Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of a Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients
Study Start Date : August 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Retia Non-Invasive Sensors
Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
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.

Primary Outcome Measures :
  1. Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output [ Time Frame: 8 hours post cardiac surgery ]
    The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01675063

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Retia Medical
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Principal Investigator: James M Blum, MD University of Michigan

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Responsible Party: Dr. James M. Blum, Assistant Professor Of Anesthesiology, Director of Critical Care Research, University of Michigan Identifier: NCT01675063     History of Changes
Other Study ID Numbers: UM HUM 63973
First Posted: August 29, 2012    Key Record Dates
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No