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)

August 8, 2013 updated by: Michael Sander, Charite University, Berlin, Germany

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Nexfin
Nexfin is used in all patients
Device: NexFin
noninvasive finger cuff system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (Estimate)

December 21, 2010

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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