Minimally Invasive Cardiac Output Monitoring Device

Cardiac Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01675063
• Other study ID #: UM HUM 63973
• Status: Active, not recruiting
• Phase: N/A
• First received: August 27, 2012
• Last updated: August 16, 2015
• Start date: August 2012
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Event

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Retia Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of an auto-calibration algorithm to measure cardiac output		8 hours post cardiac surgery	No