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

NCT ID: NCT01263990

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Stroke Volume Mean Arterial Pressure

Keywords

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hemodynamic monitoring systems stroke volume

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nexfin

Nexfin is used in all patients

Group Type NO_INTERVENTION

NexFin

Intervention Type DEVICE

noninvasive finger cuff system

Interventions

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NexFin

noninvasive finger cuff system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Michael Sander

Vice Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Sander, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

Claudia Spies, MD

Role: STUDY_CHAIR

Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

Locations

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

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EA1/199/10

Identifier Type: OTHER

Identifier Source: secondary_id

VaSNex

Identifier Type: -

Identifier Source: org_study_id