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Minimally Invasive Cardiac Output Monitoring Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01675063
Recruitment Status : Completed
First Posted : August 29, 2012
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Retia Medical
Information provided by (Responsible Party):
Dr. James M. Blum, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Cardiac Event
Intervention Device: Retia Non-Invasive Sensors
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Retia Non-Invasive Sensors
Hide Arm/Group Description

Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

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.

Period Title: Overall Study
Started 77
Completed 77
Not Completed 0
Arm/Group Title Retia Non-Invasive Sensors
Hide Arm/Group Description

Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

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.

Overall Number of Baseline Participants 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  36.4%
>=65 years
49
  63.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 77 participants
69
(35 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants
Female
31
  40.3%
Male
46
  59.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77 participants
77
1.Primary Outcome
Title Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output
Hide Description 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.
Time Frame 8 hours post cardiac surgery
Hide Outcome Measure Data
Hide Analysis Population Description
patients had undergone routine cardiac surgery. some patients did not have PA catheters placed and subsequently data was not obtained on cardiac output.
Arm/Group Title Retia Non-Invasive Sensors
Hide Arm/Group Description:

Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

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.

Overall Number of Participants Analyzed 77
Measure Type: Count of Participants
Unit of Measure: Participants
analyzable data obtained
75
  97.4%
data flawed and unable to analyze
2
   2.6%
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Retia Non-Invasive Sensors
Hide Arm/Group Description

Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.

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.

All-Cause Mortality
Retia Non-Invasive Sensors
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Retia Non-Invasive Sensors
Affected / at Risk (%)
Total   0/77 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Retia Non-Invasive Sensors
Affected / at Risk (%)
Total   0/77 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI is not involved with the ultimate analysis of the data which is to be used for proprietary algorithm development. The PI was engaged with his opinion on algorithm development and review of waveform data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Blum
Organization: Emory University
Phone: 404-778-3482
EMail: jmblum@emory.edu
Layout table for additonal information
Responsible Party: Dr. James M. Blum, University of Michigan
ClinicalTrials.gov Identifier: NCT01675063     History of Changes
Other Study ID Numbers: UM HUM 63973
First Submitted: August 27, 2012
First Posted: August 29, 2012
Results First Submitted: October 11, 2016
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017