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
  Purpose
  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 Intervention Phase
Cardiac Output
Device: Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements [ Time Frame: perioperative period ] [ Designated as safety issue: No ]

    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:
  • Safety of Device Measured by Number of Participants With Adverse Events [ Time Frame: perioperative period ] [ Designated as safety issue: Yes ]
    Patients were interviewed postoperatively for all complications and specifically for complications related to intubation and/or cardiac output measurements


Enrollment: 261
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924482

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

Additional Information:
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

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

ClinicalTrials.gov processed this record on April 17, 2014