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

This study has been completed.
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01376518
First received: June 14, 2011
Last updated: June 17, 2011
Last verified: August 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patients on intensive care unit with acute respiratory failure

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376518

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

No publications provided

Responsible Party: Patrick Schramm, Johannes Gutenberg-University Mainz
ClinicalTrials.gov Identifier: NCT01376518     History of Changes
Other Study ID Numbers: 837.041.10 1
Study First Received: June 14, 2011
Last Updated: June 17, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013