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

Completed

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

• Registration Number: NCT01791283
• Lead Sponsor: University Hospital, Linkoeping

Brief Summary

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

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 Timeline

• Study Start: 2012-08
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Last Update Submitted: 2013-02-12
• Study First Posted: 2013-02-13
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Departement for intensive care medicine, Universitetssjukhuset; 🇸🇪 Linkoping, Sweden