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Influence Positive End-expiratory Pressure on Autoregulation in Patients With Respiratory Insufficiency (dARICUPEEP)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
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:
Johannes Gutenberg University Mainz
The aim of the present study is to characterize the influence of an elevated positive end-expiratory pressure in patients with acute respiratory distress syndrome or acute lung injury on the cerebrovascular autoregulation.

Condition Intervention
Respiratory Insufficiency Procedure: positive end-expiratory pressure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Influence of Positive End-expiratory Pressure on the Cerebrovascular Autoregulation in Patients With Respiratory Failure

Resource links provided by NLM:

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Change from Baseline cerebrovascular autoregulation due to elevated positive end-expiratory pressure [ Time Frame: 1 Year ]
    Is there an impairment of cerebrovascular autoregulation due to positive end-expiratory pressure ventilation this will be a major side effect especial in patients with brain injury.

Enrollment: 20
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
respiratory failure
patients with respiratory failure and need of high positive end-expiratory pressure ventilation.
Procedure: positive end-expiratory pressure
Elevation of positive end-expiratory failure for recruitment
Other Name: PEEP

Detailed Description:
Cerebral blood flow velocity will be measured using transcranial Doppler sonography and then correlate with the invasive arterial blood pressure curve to calculate the index of cerebrovascular autoregulation Mx (Mx>0.3 indicates impaired AR). The index of cerebrovascular autoregulation Mx was measured during baseline positive end-expiratory pressure (PEEP) levels and after lung recruitment with higher level of PEEP. The equality between this two PEEP levels was estimated and calculated with one side Wilcoxon test.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients on intensive care unit with acute respiratory failure

Inclusion Criteria:

  • respiratory failure
  • Age >18 years
  • Invasive ventilation

Exclusion Criteria:

  • Sepsis
  • preexisting cerebral illness
  • traumatic brain injury
  • meningitis or encephalitis
  • pregnancy
  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): NCT01376518

University medical centre
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Principal Investigator: Patrick Schramm, MD Department of Anesthesiology, University medicine Mainz, Germany
  More Information

Responsible Party: Patrick Schramm, Johannes Gutenberg-University Mainz
ClinicalTrials.gov Identifier: NCT01376518     History of Changes
Other Study ID Numbers: 837.041.10 1
First Submitted: June 14, 2011
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
Last Verified: August 2010

Keywords provided by Johannes Gutenberg University Mainz:
acute respiratory distress syndrome
acute lung injury
cerebrovascular autoregulation
transcranial Doppler

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases