Validation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, FloTrac and TEE (VaSNex)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Michael Sander, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01263990

First received: December 14, 2010

Last updated: August 8, 2013

Last verified: August 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2010

Last Updated Date

August 8, 2013

Start Date ^ICMJE

September 2010

Primary Completion Date

May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

stroke volume [ Time Frame: preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01263990 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

mean arterial pressure [ Time Frame: preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Validation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, FloTrac and TEE

Official Title ^ICMJE

Prospective, Monocentric Pilot Study for the Validation of Stroke Volume by Use of NexFin in Comparison to Different Hemodynamic Monitoring Procedures (Picco2, FloTrac and TEE)

Brief Summary

Main hypothesis: there is no difference between stroke volume measurements recorded by a new noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as Picco2-system, FloTrac and transesophageal echocardiography

Detailed Description

In high risc patients undergoing orthopedic surgery an extended cardiopulmonary observation improves patients safety and postoperative outcome. Therefore invasive procedures as Picco2-system, FloTrac and transesophageal echocardiography (tee) have the advantage to measure or calculate stroke volume. Disadvantage of this treatments is the need for a vascular access with all its complications.

In this study the stroke volume measured by a new noninvasive finger cuff system (NexFin) should be validated in comparison to invasive hemodynamic monitoring systems as Picco2-system, FloTrac and tee.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Stroke Volume
Mean Arterial Pressure

Intervention ^ICMJE

Device: NexFin

noninvasive finger cuff system

Study Arms

No Intervention: Nexfin

Nexfin is used in all patients

Intervention: Device: NexFin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2013

Primary Completion Date

May 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients undergoing orthopedic surgery with need for invasive blood pressure measurements
age ≥ 18 years
signed informed consent
no participation on another interventional study

Exclusion Criteria:

refusal of participation
patients who are not able to sign informed consent
atrial fibrillation with arrhythmia
peripheral arterial disease > Fontain IIa
scleroderma
presence of an arterio-venous shunt on upper limb
contraindication for femoral arterial vascular access
contraindication for transesophageal echocardiography
stage III heart valve defects
shunt heart defects
solitary regional anaesthesia
pregnant or breastfeeding women

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01263990

Other Study ID Numbers ^ICMJE

VaSNex
EA1/199/10 ( Other Identifier: Charité Ethics Commission )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Michael Sander, Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Michael Sander, MD	Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Study Chair:	Claudia Spies, MD	Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

PRS Account

Charite University, Berlin, Germany

Verification Date

August 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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