Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM)

This study has been completed.
Sponsor:
Collaborator:
ConMed Corporation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00924482
First received: June 17, 2009
Last updated: August 29, 2013
Last verified: August 2013
Results First Received: September 23, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Cardiac Output
Intervention: Device: Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Cardiac output measurements were made in adult patients undergoing cardiac surgery at the San Francisco VA Medical Center. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Design of the ECOM system and algorithm as well as safety testing were done using an animal model. The initial participants were used to finalize the system and model of the relationship between true and impedance-derived measurement of cardiac output. The final algorithm and electronics were tested in the last 101 enrolled participants.

Reporting Groups
  Description
Adult Cardiac Surgery Patients

Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.

Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique.

Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method.


Participant Flow:   Overall Study
    Adult Cardiac Surgery Patients  
STARTED     261  
COMPLETED     261  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Study analyses included the final n=101 who had the approved clinical electronics and clinical tube; no changes in tube, algorithm or electronic design were allowed during this part of the study. Experimental electronics and version of the tube were used to test and finalize the design and algorithm during enrollment of the earlier patient group.

Reporting Groups
  Description
Adult Cardiac Surgery Patients

Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.

Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.

Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method.


Baseline Measures
    Adult Cardiac Surgery Patients  
Number of Participants  
[units: participants]
  101  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 9  
Gender  
[units: participants]
 
Female     0  
Male     101  
Region of Enrollment  
[units: participants]
 
United States     101  
Weight  
[units: kg]
Mean ± Standard Deviation
  91  ± 19  
Height  
[units: cm]
Mean ± Standard Deviation
  175  ± 8  
Body Surface Area  
[units: meters^2]
Mean ± Standard Deviation
  2.1  ± 0.2  
Ejection Fraction  
[units: percent]
Mean ± Standard Deviation
  56  ± 12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements   [ Time Frame: perioperative period ]

2.  Secondary:   Safety of Device Measured by Number of Participants With Adverse Events   [ Time Frame: perioperative period ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Arthur Wallace, M.D., Ph.D.
Organization: University of California San Francisco
phone: 415-750-2069 ext 3732
e-mail: wallacea@anesthesia.ucsf.edu


Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00924482     History of Changes
Other Study ID Numbers: H7565-14654
Study First Received: June 17, 2009
Results First Received: September 23, 2010
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration