Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement

Validation of Electrical Cardiometry Versus Fick Method to Measure Stroke Volume and Cardiac Output in Patients With or Suspected of Having Heart Failure

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01568619

Enrollment

Registered

2012-04-02

Start date

2012-03-31

Completion date

2015-10-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

cardiopulmonary exercise test, cardiac output

Brief summary

The investigators would like to find out if AESCULON®, a new device that non-invasively and continuously measures cardiac output using electrical cardiometry, works as well as one existing method--Fick method in patients undergoing cardiopulmonary exercise testing.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \>= 18 yd; * Level 3 cardiopulmonary exercise testing.

Exclusion criteria

* Proven or suspected disease involving severe aortic regurgitation; * Implanted with a rate-responsive cardiac pacemaker; * Pneumothorax or pleural effusion; * Skin lesion(s) at the place where the electrode is supposed to be applied; * Allergic to adhesive of ECG electrodes.

Design outcomes

Primary

Measure	Time frame	Description
difference in CO measurements with two methods	two weeks after finishing the exercise test	the true difference between the two CO measurements is 10% of the mean CO

Countries

United States

Outcome results