CNAP Accuracy Dependent on Hemodynamic Variables

This study is currently recruiting participants.
Verified November 2012 by University of Schleswig-Holstein
Sponsor:
Information provided by (Responsible Party):
Dr. Jochen Renner, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01743846
First received: December 4, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

Agreement of CNAP pressure with invasive pressure is evaluated dependent on hemodynamic variables achieved by a PICCO monitor.

Hypothesis: Low cardiac output and volume status but not high vascular resistance affect the accuracy of CNAP.


Condition
Accuracy and Precision of Noninvasive Measurement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Measurements Dependent on Cardiac Function, Vascular Resistance and Volume Status

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • arterial pressure [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Accuracy and precision of CNAP in comparison with the gold standard


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Major Surgery
Patients undergoing major surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing major surgery under general anaesthesia

Criteria

Inclusion Criteria:

  • need for invasive blood pressure measurement

Exclusion Criteria:

  • age under 18
  • emergencies
  • cardiac dysrhythmia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743846

Locations
Germany
University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine Recruiting
Kiel, Germany, 24106
Contact: Jochen Renner, PD Dr.    0049-0431-597 3694      
Principal Investigator: Jochen Renner, PD Dr.         
Sub-Investigator: Christoph Ilies, Dr         
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Jochen Renner, PD Dr. University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine
Principal Investigator: Robert Hanss, Prof. Dr. University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine
  More Information

No publications provided

Responsible Party: Dr. Jochen Renner, PD Dr. med Jochen Renner, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01743846     History of Changes
Other Study ID Numbers: CNAP 2010_3
Study First Received: December 4, 2012
Last Updated: December 4, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on April 17, 2014