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

December 14, 2010
August 8, 2013
September 2010
May 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01263990 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Validation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, FloTrac and TEE
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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Stroke Volume
  • Mean Arterial Pressure
Device: NexFin
noninvasive finger cuff system
No Intervention: Nexfin
Nexfin is used in all patients
Intervention: Device: NexFin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01263990
VaSNex, EA1/199/10
Yes
Michael Sander, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Michael Sander, MD Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Study Chair: Claudia Spies, MD Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Charite University, Berlin, Germany
August 2013

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