NCT01263990

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

1.7 years

First QC Date

December 14, 2010

Last Update Submit

August 8, 2013

Conditions

Stroke VolumeMean Arterial Pressure

Keywords

hemodynamic monitoring systemsstroke volume

Outcome Measures

Primary Outcomes (1)

  • stroke volume

    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

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

Study Arms (1)

Nexfin

NO INTERVENTION

Nexfin is used in all patients

Device: NexFin

Interventions

NexFinDEVICE

noninvasive finger cuff system

Nexfin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing orthopedic surgery with need for invasive blood pressure measurements
  • age ≥ 18 years
  • signed informed consent
  • no participation on another interventional study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, 10117, Germany

Location

Study Officials

  • Michael Sander, MD

    Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

    PRINCIPAL INVESTIGATOR

  • Claudia Spies, MD

    Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 21, 2010

Study Start

September 1, 2010

Primary Completion

May 1, 2012

Study Completion

June 1, 2013

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

DE(1)