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

NCT00924482 | Completed Phase 2 Results DMC

• 1 other identifier: H7565-14654
• Study Type: interventional
• Target: 261
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.Establish the safety and efficacy of the ECOM system.

Conditions

Cardiac Output

Keywords

cardiac output; ECOM; Endotracheal Cardiac Output Monitor; Perioperative medical care

Outcome Measures

Primary Outcomes (1)

• Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements

  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).

  perioperative period

Secondary Outcomes (1)

• Safety of Device Measured by Number of Participants With Adverse Events

  perioperative period

Study Arms (1)

Single Arm - Device

OTHER

Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery

Device: Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery

Interventions

Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery DEVICE

Measure cardiac output during perioperative period and compare to pulmonary artery thermodilution cardiac output measurements.

Single Arm - Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients able to give informed consent.
• Patients undergoing cardiac surgery which would routinely require:
• an endotracheal tube
• pulmonary artery catheter

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• CONMED Corporation: collaborator

Related Publications (1)

• Wallace AW, Salahieh A, Lawrence A, Spector K, Owens C, Alonso D. Endotracheal cardiac output monitor. Anesthesiology. 2000 Jan;92(1):178-89. doi: 10.1097/00000542-200001000-00030.

  PMID: 10638915 BACKGROUND

Results Point of Contact

• Title: Arthur Wallace, M.D., Ph.D.
• Organization: University of California San Francisco

wallacea@anesthesia.ucsf.edu

415-750-2069

Study Officials

• Art Wallace, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: January 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 28, 2023
• Results First Posted: September 2, 2013

Record last verified: 2023-11