Accuracy of CNAP PPV Under General Anaesthesia

June 3, 2017 updated by: Dr. Jochen Renner, University Hospital Schleswig-Holstein

Comparison of the Non-invasive CNAP Pulse Pressure Variation With the Invasive Gold Standard

Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is compared with the gold standard of invasive measurements. Cardiac output is derived by the PICCO monitor.

Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the prediction of fluid responsiveness will be defined.

Study Overview

Status

Completed

Conditions

Detailed Description

Accuracy of PPV measured by two devices,PICCO and CNAP, is compared with the manually calculated PPV from the arterial line waveform. Established tests like passive leg raising and end-expiratory occlusion are used for prediction of fluid responsiveness. Intraoperative events like volume challenge are monitored.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing major surgery with the need for invasive arterial pressure monitoring

Description

Inclusion Criteria:

  • major surgery
  • need for invasive arterial measurements

Exclusion Criteria:

  • age under 18
  • cardiac dysrhythmia
  • vascular pathology at punction site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output
Time Frame: 1, 2, 5, 10, 15 and 20 minutes after volume challange and
Improvement of cardiac output dependent on PPV before volume challenge
1, 2, 5, 10, 15 and 20 minutes after volume challange and

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

June 15, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 3, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CNAP 2012_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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