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

Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously. Clinical Trial

— FourComp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791283
• Other study ID #: FourCompv1
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: February 12, 2013
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.

Intervention

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

Locations

Country	Name	City	State
Sweden	Departement for intensive care medicine, Universitetssjukhuset	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No