Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement

Completed

• Conditions: Heart Failure

• Registration Number: NCT01568619
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-02
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-15
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States