N/A N=77 Other

Minimally Invasive Cardiac Output Monitoring Device

Cardiac Event

Bottom Line

View on ClinicalTrials.gov: NCT01675063 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output — 75; 2 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Retia Non-Invasive Sensors (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output	75; 2	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01675063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.