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

Stroke Volume Clinical Trial

— VaSNex  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263990
• Other study ID #: VaSNex
• Secondary ID: EA1/199/10
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: August 8, 2013
• Start date: September 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mean Arterial Pressure
• Stroke
• Stroke Volume

Intervention

Device:
• NexFin
noninvasive finger cuff system

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke volume		preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery	No
Secondary	mean arterial pressure		preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery	No