Clinical trial NCT01263990: Validation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Volume
Mean Arterial Pressure
Keywords: hemodynamic monitoring systems
stroke volume
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: stroke volume
timeFrame: preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery
Secondary outcomes:
measure: mean arterial pressure
timeFrame: preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Study officials:
affiliation: Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
name: Michael Sander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
name: Claudia Spies, MD
role: STUDY_CHAIR
References: