Minimally Invasive Cardiac Output Monitoring Device

Not Applicable

Completed

• Conditions: Cardiac Event
• Interventions: Device: Retia Non-Invasive Sensors

• Registration Number: NCT01675063
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-27
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-10-11
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-27
• Last Update Submitted: 2017-03-27
• Results First Posted: 2017-05-08
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• All adult patients admitted to the University of Michigan ICU following cardiac surgery with both a pulmonary and radial artery catheter.

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Exclusion Criteria

• Adult patients with mechanical cardiac support including intra-aortic balloon pumps, LVAD, or ECMO, and persistent ventricular arrhythmias.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Retia Non-Invasive Sensors	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.

Primary Outcome Measures

Name	Time	Method
Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States