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CNAP Accuracy Dependent on Hemodynamic Variables

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743846
First Posted: December 6, 2012
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Jochen Renner, University of Schleswig-Holstein
  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 Dr. Jochen Renner, University of Schleswig-Holstein:

Primary Outcome Measures:
  • arterial pressure [ Time Frame: intraoperative ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 4, 2012
First Posted: December 6, 2012
Last Update Posted: December 8, 2015
Last Verified: December 2015