Phase 3
N=261
Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM)
Cardiac Output
Bottom Line
View on ClinicalTrials.gov: NCT00924482 ↗Enrolled (actual)
261
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements — 0.31 liters/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placed ECOM endotracheal cardiac output monitor in patients undergoing cardiac surgery (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2008
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 |
— | — |
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.
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.
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.