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Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement

This study is currently recruiting participants.
Verified March 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01568619
First received: March 29, 2012
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

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 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568619

Contacts
Contact: Yandong Jiang, M.D., Ph.D. 617-447-9707 YJIANG@PARTNERS.ORG
Contact: Gregory D Lewis, MD 617-726-9554 GLEWIS@PARTNERS.ORG

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yandong Jiang, M.D., Ph.D.     617-447-9707     YJIANG@PARTNERS.ORG    
Principal Investigator: Yandong Jiang, MD, PhD            
Principal Investigator: Gregory D Lewis, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Yandong Jiang, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01568619     History of Changes
Other Study ID Numbers: AESCULON
Study First Received: March 29, 2012
Last Updated: March 30, 2012
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

ClinicalTrials.gov processed this record on June 17, 2013