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

Not Applicable

Completed

• Conditions: Stroke Volume; Mean Arterial Pressure
• Interventions: Device: NexFin

• Registration Number: NCT01263990
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Primary Completion: 2012-05
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nexfin	NexFin	Nexfin is used in all patients

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
mean arterial pressure	preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany