Minimally Invasive Cardiac Output Monitoring Device

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Event
• Intervention / Treatment: Device: Retia Non-Invasive Sensors

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output	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.	8 hours post cardiac surgery

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Retia Medical
• Investigators: Principal Investigator: James M Blum, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 27, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 29, 2012

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: UM HUM 63973

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No