Phase 3 Completed N=261 Prevention

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

Cardiac Output

Source: ClinicalTrials.gov NCT00924482 ↗

Enrolled (actual)

261

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcomePrimary: Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements — 0.31 liters/min

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements	0.31	—
SECONDARY Safety of Device Measured by Number of Participants With Adverse Events	—	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00924482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.