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OpenTrials
Completed

NCT Number: 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

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

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Key information

Conditions

Stroke Volume Mean Arterial Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nexfin

Device

noninvasive finger cuff system

Primary outcomes

  1. 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

  1. mean arterial pressure

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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)

Acronym: VaSNex

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 21, 2010
Registry last updated
Aug 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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