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Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods (FourComp)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791283
First Posted: February 13, 2013
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anna Oscarsson, University Hospital, Linkoeping
  Purpose
Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac magnetic resonance imaging (CMRI)

Condition Intervention
Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously. Procedure: Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods

Resource links provided by NLM:


Further study details as provided by Anna Oscarsson, University Hospital, Linkoeping:

Primary Outcome Measures:
  • Limits of agreement (LOA) is less than 30% using CMRI as validation for each individual measurement of left ventricular stroke volume. [ Time Frame: Study period (1 month) ]

Enrollment: 20
Study Start Date: August 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteers
Healthy volounteers with no previous medical history, age between 20-40. Both male and female. Subjects are provided extensive information about the study and the obligations and expectations included. All subjects sign a witnessed informed consent before inclusion.
Procedure: Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.
Other Names:
  • Vigileo/FloTrac, Edward Lifesciences (arterial waveform analysis)
  • CardioQ, Deltex medical (esofageal doppler)
  • Philips, Magnetic Resonance Imaging
  • Vivid S6, GE, Cardiac ultrasound

Detailed Description:
20 healthy volounteers between age of 20-40 years, no previous medical history undergo simoultaneous left ventrikular strokevolume measurements using three different methods at rest. After datasampling and without moving, the subject then undergo Cardiac Magnetic Resonance Imaging with 2D-throughplane and cine tecnology for validation of volume measurements. The data is then analyzed using Bland-Altman calculation.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volounteers
Criteria

Inclusion Criteria:Healthy volounteers age 20-40, BMI < 30, weight < 100 kg, no medications, sinus rythm on ECG, no contra-indications for MRI, ability to give written informed consent.

Exclusion Criteria:

  • Heart and/or vascular disease such as angina pectoris, arrythmias, claudicatio intermittens e g.
  • Diseases in gastrointestinal tract or nose.
  • Coagulopathies
  • Pregnancy
  • Allergys for local anaesthetics
  • Claustrofobia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791283


Locations
Sweden
Departement for intensive care medicine, Universitetssjukhuset
Linkoping, Sweden, 581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: Goran Liffner, MD Intensivvardskliniken, Linkoping University Hospital
  More Information

Responsible Party: Anna Oscarsson, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01791283     History of Changes
Other Study ID Numbers: FourCompv1
First Submitted: February 12, 2013
First Posted: February 13, 2013
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by Anna Oscarsson, University Hospital, Linkoeping:
Left ventricular stroke volume
Arterial waveform analysis
Esofageal doppler
Ultrasound
Cardiac magnetic Imaging
Limits of agreement