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Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital Identifier:
First received: March 29, 2012
Last updated: December 1, 2014
Last verified: December 2014
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.

Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of Electrical Cardiometry Versus Fick Method to Measure Stroke Volume and Cardiac Output in Patients With or Suspected of Having Heart Failure

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • difference in CO measurements with two methods [ Time Frame: two weeks after finishing the exercise test ] [ Designated as safety issue: No ]
    the true difference between the two CO measurements is 10% of the mean CO

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients of 18 years or older who undergo cardiopulmonary exercise testing (CPET) with invasive hemodynamic monitoring for their routine care.

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.
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Please refer to this study by its identifier: NCT01568619

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: Yandong Jiang, Assistant Professor, Massachusetts General Hospital Identifier: NCT01568619     History of Changes
Other Study ID Numbers: AESCULON 
Study First Received: March 29, 2012
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
cardiopulmonary exercise test
cardiac output

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on December 02, 2016