CNAP Accuracy Dependent on Hemodynamic Variables

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Jochen Renner, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01743846
First received: December 4, 2012
Last updated: December 5, 2015
Last verified: December 2015
  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


Enrollment: 50
Study Start Date: January 2014
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Major Surgery
Patients undergoing major surgery

Detailed Description:

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. Body mass index and age may have impact on the accuracy of PPV measured non-invasively on the basis of volume-clamp technique.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01743846

Locations
Germany
University Hospital, Schleswig-Holstein. Departement of Anaesthesia and Intensive Care Medicine
Kiel, Germany, 24106
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

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 5, 2015
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on July 28, 2016