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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01263990

Acronym

VaSNex

Enrollment

Registered

2010-12-21

Start date

2010-09-30

Completion date

2013-06-30

Last updated

2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mean Arterial Pressure, Stroke Volume

Keywords

hemodynamic monitoring systems, stroke volume

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.

Interventions

DEVICENexFin

noninvasive finger cuff system

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026