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NCT01376518 Clinical Trial

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

Respiratory Insufficiency Clinical Trial

— dARICUPEEP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01376518
Other study ID # 837.041.10 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2011
Est. completion date June 2011

Study information
Verified date June 2020
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- respiratory failure

- Age >18 years

- Invasive ventilation

Exclusion Criteria:

- Sepsis

- preexisting cerebral illness

- traumatic brain injury

- meningitis or encephalitis

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• positive end-expiratory pressure
Elevation of positive end-expiratory failure for recruitment

Locations
Country Name City State
Germany University medical centre Mainz

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schramm P, Closhen D, Felkel M, Berres M, Klein KU, David M, Werner C, Engelhard K. Influence of PEEP on cerebral blood flow and cerebrovascular autoregulation in patients with acute respiratory distress syndrome. J Neurosurg Anesthesiol. 2013 Apr;25(2):1 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Integrity of the cerebrovascular autoregulation (CA) 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
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