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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02166580
Other study ID # CNAP 2012_2
Secondary ID
Status Completed
Phase N/A
First received December 4, 2012
Last updated June 3, 2017
Start date January 2014
Est. completion date July 2015

Study information

Verified date June 2017
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- major surgery

- need for invasive arterial measurements

Exclusion Criteria:

- age under 18

- cardiac dysrhythmia

- vascular pathology at punction site

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital, Schleswig-Holstein. Departement of Anaesthesiology and Intensive Care Medicine Kiel

Sponsors (1)

Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac output Improvement of cardiac output dependent on PPV before volume challenge 1, 2, 5, 10, 15 and 20 minutes after volume challange and
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