Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM) (ECOM)
- 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.
- Establish the safety and efficacy of the ECOM system.
|Cardiac Output||Device: Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery||Phase 2 Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM)|
- 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).
- 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
|Study Start Date:||January 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924482
|Principal Investigator:||Art Wallace, MD, PhD||University of California, San Francisco|