ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01376518
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : June 20, 2011
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz

Brief Summary:
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 or disease Intervention/treatment
Respiratory Insufficiency Procedure: positive end-expiratory pressure

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.

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Influence of Positive End-expiratory Pressure on the Cerebrovascular Autoregulation in Patients With Respiratory Failure
Study Start Date : January 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

Inclusion Criteria:

  • respiratory failure
  • Age >18 years
  • Invasive ventilation

Exclusion Criteria:

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

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


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

Responsible Party: Patrick Schramm, Johannes Gutenberg-University Mainz
ClinicalTrials.gov Identifier: NCT01376518     History of Changes
Other Study ID Numbers: 837.041.10 1
First Posted: June 20, 2011    Key Record Dates
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
ventilation

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