Influence Positive End-expiratory Pressure on Autoregulation in Patients With Respiratory Insufficiency (dARICUPEEP)
This study has been completed.
Sponsor:
Johannes Gutenberg University Mainz
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 14, 2011 | ||||
| Last Updated Date | June 17, 2011 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01376518 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Influence Positive End-expiratory Pressure on Autoregulation in Patients With Respiratory Insufficiency | ||||
| Official Title ICMJE | Influence of Positive End-expiratory Pressure on the Cerebrovascular Autoregulation in Patients With Respiratory Failure | ||||
| 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. |
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| 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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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Adult patients on intensive care unit with acute respiratory failure |
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| Condition ICMJE | Respiratory Insufficiency | ||||
| Intervention ICMJE | Procedure: positive end-expiratory pressure
Elevation of positive end-expiratory failure for recruitment
Other Name: PEEP |
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| Study Group/Cohort (s) | respiratory failure
patients with respiratory failure and need of high positive end-expiratory pressure ventilation.
Intervention: Procedure: positive end-expiratory pressure |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01376518 | ||||
| Other Study ID Numbers ICMJE | 837.041.10 1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Patrick Schramm, Johannes Gutenberg-University Mainz | ||||
| Study Sponsor ICMJE | Johannes Gutenberg University Mainz | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Johannes Gutenberg University Mainz | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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