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

June 19, 2020 updated by: Patrick Schramm, Johannes Gutenberg University Mainz

Influence of Positive End-expiratory Pressure on the Cerebrovascular Autoregulation in Patients With Respiratory Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

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
      • Mainz, Germany, 55131
        • University Medical Centre

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients on intensive care unit with acute respiratory failure

Description

Inclusion Criteria:

  • respiratory failure
  • Age >18 years
  • Invasive ventilation

Exclusion Criteria:

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

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

Cohorts and Interventions

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 Names:
  • PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Integrity of the cerebrovascular autoregulation (CA)
Time Frame: 30 Minutes
Cerebrovascular autoregulation will be calculated as a moving correlation index (Mx) from the cerebral blood flow velocity and the arterial blood pressure. It is a parameter without unit (index).
30 Minutes

Collaborators and Investigators

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

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Patrick Schramm, MD, Department of Anesthesiology, University medicine Mainz, Germany

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, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

June 17, 2011

First Posted (Estimate)

June 20, 2011

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 837.041.10 1

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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