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

Study Overview
=================
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.

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)

Conditions
-----------------
Stroke Volume, Mean Arterial Pressure

Intervention / Treatment
-----------------
* Device: NexFin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Nexfin<br>Nexfin is used in all patients | Device: NexFin<br>* noninvasive finger cuff system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodynamic monitoring systems, stroke volume