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Clinical Trials/NCT01675063
NCT01675063
Completed
Not Applicable

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

University of Michigan1 site in 1 country77 target enrollmentAugust 2012
ConditionsCardiac Event

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Event
Sponsor
University of Michigan
Enrollment
77
Locations
1
Primary Endpoint
Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
October 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. James M. Blum

Assistant Professor Of Anesthesiology, Director of Critical Care Research

University of Michigan

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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