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Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01568619
First received: March 29, 2012
Last updated: December 1, 2014
Last verified: December 2014
  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:


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)
  Eligibility

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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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: 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

ClinicalTrials.gov processed this record on September 26, 2016