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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Oscarsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01791283
First received: February 12, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted

February 12, 2013
February 12, 2013
August 2012
February 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods
Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods

Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac magnetic resonance imaging (CMRI)

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Healthy volounteers

Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.
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
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.
Intervention: Procedure: Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01791283
FourCompv1
Yes
Anna Oscarsson, University Hospital, Linkoeping
University Hospital, Linkoeping
Not Provided
Principal Investigator: Goran Liffner, MD Intensivvardskliniken, Linkoping University Hospital
University Hospital, Linkoeping
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP