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

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

Study Overview

• Status: Completed
• Conditions: Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.
• Intervention / Treatment: Procedure: Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Sweden
  • Linkoping, Sweden, 581 85
    • Departement for intensive care medicine, Universitetssjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volounteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Investigators: Principal Investigator: Goran Liffner, MD, Intensivvardskliniken, Linkoping University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Ultrasound; Arterial waveform analysis; Left ventricular stroke volume; Esofageal doppler; Cardiac magnetic Imaging; Limits of agreement
• Other Study ID Numbers: FourCompv1