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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01263990
First received: December 14, 2010
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Stroke Volume
Mean Arterial Pressure
 Device: NexFin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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)

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • stroke volume [ Time Frame: preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean arterial pressure [ Time Frame: preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: August 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Nexfin
Nexfin is used in all patients
 Device: NexFin
noninvasive finger cuff system

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263990

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, Germany, 10117
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Michael Sander, Vice Chair, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01263990     History of Changes
Other Study ID Numbers: VaSNex, EA1/199/10
Study First Received: December 14, 2010
Last Updated: December 17, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
hemodynamic monitoring systems
stroke volume

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 19, 2013