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
  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 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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
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.

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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
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: 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

No publications provided

Responsible Party: Anna Oscarsson, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01791283     History of Changes
Other Study ID Numbers: FourCompv1
Study First Received: February 12, 2013
Last Updated: February 12, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014