Minimally Invasive Cardiac Output Monitoring Device
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|ClinicalTrials.gov Identifier: NCT01675063|
Recruitment Status : Completed
First Posted : August 29, 2012
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Event||Device: Retia Non-Invasive Sensors||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of a Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Retia Non-Invasive Sensors
Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675063
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||James M Blum, MD||University of Michigan|