Completed

NCT Number: NCT01791283

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)

Completed

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Key information

Conditions

Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Departement for intensive care medicine, Universitetssjukhuset

Linköping, 581 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.

Procedure

Other names: Vigileo/FloTrac, Edward Lifesciences (arterial waveform analysis), CardioQ, Deltex medical (esofageal doppler), Philips, Magnetic Resonance Imaging, Vivid S6, GE, Cardiac ultrasound

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Acronym: FourComp

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Feb 13, 2013
Registry last updated: Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.