CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
Retia Non-Invasive Sensorsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01675063
NCT01675063N/ACompleted

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

University of Michigan·interventional·Posted Aug 29, 2012·Updated May 8, 2017

In Brief

A clinical study evaluating Retia Non-Invasive Sensors for Cardiac Event. Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Event
CountriesUnited States
CollaboratorsRetia Medical

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2012
Enrollment StartAug 1, 2012
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.8 years ago

Interventions

Retia Non-Invasive Sensorsdevice

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.