Back to resultsValidation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, FloTrac and TEE (VaSNex)
Primary Purpose
Stroke Volume, Mean Arterial Pressure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NexFin
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke Volume focused on measuring hemodynamic monitoring systems, stroke volume
Eligibility 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
Sites / Locations
- Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Nexfin
Arm Description
Nexfin is used in all patients
Outcomes
Primary Outcome Measures
stroke volume
Secondary Outcome Measures
mean arterial pressure
Full Information
NCT ID
NCT01263990
First Posted
December 14, 2010
Last Updated
August 8, 2013
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01263990
Brief Title
Validation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, FloTrac and TEE
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Volume, Mean Arterial Pressure
Keywords
hemodynamic monitoring systems, stroke volume
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nexfin
Arm Type
No Intervention
Arm Description
Nexfin is used in all patients
Intervention Type
Device
Intervention Name(s)
NexFin
Intervention Description
noninvasive finger cuff system
Primary Outcome Measure Information:
Title
stroke volume
Time Frame
preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery
Secondary Outcome Measure Information:
Title
mean arterial pressure
Time Frame
preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Sander, MD
Organizational Affiliation
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD
Organizational Affiliation
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Validation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, FloTrac and TEE
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