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

Charite University, Berlin, Germany20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Stroke Volume Mean Arterial Pressure

Interventions

NexFinDEVICE

noninvasive finger cuff system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Berlin, Germany

Outcomes

Primary Outcomes

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 Outcomes

mean arterial pressure

Time frame: preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery

Data from ClinicalTrials.gov

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