CNAP Accuracy Dependent on Hemodynamic Variables

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 15, 2014
Last verified: June 2014
  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: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 15, 2014
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on September 18, 2014