N/A
Completed N=77
Minimally Invasive Cardiac Output Monitoring Device
Cardiac Event
Source: ClinicalTrials.gov NCT01675063 ↗
Enrolled (actual)
77
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output — 75; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output |
75; 2 | — |
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.
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. Informational only — not medical advice.