Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM) (ECOM)
|ClinicalTrials.gov Identifier: NCT00924482|
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : September 2, 2013
Last Update Posted : September 2, 2013
- 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.
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM)|
|Study Start Date :||January 2007|
|Primary Completion Date :||September 2008|
|Study Completion Date :||September 2008|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924482
|Principal Investigator:||Art Wallace, MD, PhD||University of California, San Francisco|