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OpenTrials
Completed

NCT Number: NCT01675063

Minimally Invasive Cardiac Output Monitoring Device

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.

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Key information

Conditions

Cardiac Event Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retia Non-Invasive Sensors

Device

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

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Retia Medical

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 29, 2012
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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