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

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ClinicalTrials.gov Identifier: NCT00924482
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : September 2, 2013
Last Update Posted : September 2, 2013
Sponsor:
Collaborator:
ConMed Corporation
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
  1. Compare measurements of cardiac output derived from electrical measurements from electrodes on an endotracheal tube (ECOM or Endotracheal Cardiac Output Monitor) to those made from a pulmonary artery thermodilution catheter.
  2. Establish the safety and efficacy of the ECOM system.

Condition or disease Intervention/treatment Phase
Cardiac Output Device: Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM)
Study Start Date : January 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Single Arm - Device
Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery
Device: Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery
Measure cardiac output during perioperative period and compare to pulmonary artery thermodilution cardiac output measurements.




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

    Correlation measured via Linear regression between thermodilution and ECOM, included as r^2 coefficient.

    Cardiac output measured by iced-thermodilution and impedance cardiography. Management of the patients done using (standard) thermodilution derived cardiac output measurements only. The ECOM endotracheal cardiac output measurements are for research purposes only and not used in the management of the patient.

    ECOM Impedance cardiography measured in the ICU when routine thermodilution cardiac output measurements are made. Endotracheal impedance measurements (ECOM) continued until tracheal extubation. Correlation with thermodilution measurements stopped when either the endotracheal tube or the thermodilution catheter was removed (post op day 0 routinely).



Secondary Outcome Measures :
  1. Safety of Device Measured by Number of Participants With Adverse Events [ Time Frame: perioperative period ]
    Patients were interviewed postoperatively for all complications and specifically for complications related to intubation and/or cardiac output measurements



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients able to give informed consent.
  2. Patients undergoing cardiac surgery which would routinely require:

    • an endotracheal tube
    • pulmonary artery catheter

Exclusion Criteria:

  1. Patients who do not speak English.
  2. Patients not competent to give informed consent.

Information from the National Library of Medicine

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): NCT00924482


Sponsors and Collaborators
University of California, San Francisco
ConMed Corporation
Investigators
Principal Investigator: Art Wallace, MD, PhD University of California, San Francisco

Additional Information:
Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00924482     History of Changes
Other Study ID Numbers: H7565-14654
First Posted: June 19, 2009    Key Record Dates
Results First Posted: September 2, 2013
Last Update Posted: September 2, 2013
Last Verified: August 2013

Keywords provided by University of California, San Francisco:
cardiac output
ECOM
Endotracheal Cardiac Output Monitor
Perioperative medical care