Continuous Positive Airway Pressure Ventilation After Acute Ischemic Stroke
NCT ID: NCT00151177
Last Updated: 2010-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2005-04-30
2008-04-30
Brief Summary
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Non-invasive CPAP (continuous positive airway pressure)-therapy may reverse a number of these effects very shortly after initiation. The aim of the study is to test the feasibility of early non-invasive CPAP treatment starting in the first night after stroke onset, and to test its efficacy in a randomized clinical trial.
50 patients with acute ischemic stroke will be enrolled and randomly assigned to standard care PLUS CPAP treatment or standard care only. All patients randomized to the intervention group will receive CPAP therapy for the first three nights after stroke. In the fourth night, a cardiorespiratory polygraphy will be performed in patients and controls. Patients assigned to the intervention group with a respiratory distress index \> 10/h will be treated further on. On admission, day 4, and day 10 after stroke, diffusion weighted MRI imaging will be performed to determine the size of the infarction. The NIHSS score will be used to assess clinical short-term outcome on day 4 and day 10. After three months, the outcome will be determined using the modified Rankin scale.
As CPAP therapy may be more laborious for the provider, the additional work-load will be documented using pre-specified scales.
Primary hypothesis of the study is, that CPAP therapy is feasible in acute stroke patients and that the additional work load will not outweigh the benefits.
Secondary hypothesis is that patients assigned to the treatment group have smaller infarctions on MRI and less neurological deficits at 3 months after stroke.
Patients entering the study will be investigated by transcranial Doppler ultrasound in case they have sufficient temporal bone windows for insonation and no stenosis or occlusions of major brain supplying arteries by the time of investigation that disturb the intracerebral blood flow.
All intracranial arteries will be assessed before treatment, after treatment and on day 8 after the insult.
Screen shots will be taken and will be analysed by dynamic vascular ultrasound (DVA), a new software algorithm developed by NHSi, to investigate microcirculatory information from the flow spectra of the major intracranial arteries.
The data from this post-hoc analysis are compared with the data of the polysomnography and with treatment.
Primary hypothesis in this substudy is that DVA reliably identifies patients with sleep apnea on days one and four after stroke. Secondary hypothesis is that DVA can distinguish between treated patients and controls.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
treatment with three nights of CPAP ventilation starting the first night of admission
non-invasive continuous positive airway pressure ventilation
CPAP-treatment
night time CPAP-mask ventilation
B
usual Stroke Unit care
CPAP-treatment
night time CPAP-mask ventilation
Interventions
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non-invasive continuous positive airway pressure ventilation
CPAP-treatment
night time CPAP-mask ventilation
Eligibility Criteria
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Inclusion Criteria
* NIH-SS 2-20 points,
* NIH-SS subitem 1a \<=1.
Exclusion Criteria
* primary intubation,
* Congestive heart failure (NYHA \>=3),
* respiratory insufficiency
* recurrent vomiting
* absence of gag reflex,
* participation in another RCT
for the ultrasound sub-study
* absence of temporal bone window for insonation
* stenosis or occlusion of major brain supplying arteries interfering with normal blood flow
18 Years
85 Years
ALL
No
Sponsors
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New Health Sciences, Inc.
INDUSTRY
Rubel GmbH, Heiligenhaus, Germany
UNKNOWN
University Hospital Muenster
OTHER
Responsible Party
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University_Hospital_Muenster
Principal Investigators
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Darius G Nabavi, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Muenster
Locations
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University_Hospital_Muenster
Münster, , Germany
Countries
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References
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Turkington PM, Bamford J, Wanklyn P, Elliott MW. Prevalence and predictors of upper airway obstruction in the first 24 hours after acute stroke. Stroke. 2002 Aug;33(8):2037-42. doi: 10.1161/01.str.0000023576.94311.27.
Bassetti C, Aldrich MS, Quint D. Sleep-disordered breathing in patients with acute supra- and infratentorial strokes. A prospective study of 39 patients. Stroke. 1997 Sep;28(9):1765-72. doi: 10.1161/01.str.28.9.1765.
Iranzo A, Santamaria J, Berenguer J, Sanchez M, Chamorro A. Prevalence and clinical importance of sleep apnea in the first night after cerebral infarction. Neurology. 2002 Mar 26;58(6):911-6. doi: 10.1212/wnl.58.6.911.
Minnerup J, Ritter MA, Wersching H, Kemmling A, Okegwo A, Schmidt A, Schilling M, Ringelstein EB, Schabitz WR, Young P, Dziewas R. Continuous positive airway pressure ventilation for acute ischemic stroke: a randomized feasibility study. Stroke. 2012 Apr;43(4):1137-9. doi: 10.1161/STROKEAHA.111.637611. Epub 2011 Dec 22.
Other Identifiers
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NHSi2005-iCPAPAPNEASTROKE-001
Identifier Type: -
Identifier Source: secondary_id
UKM-SL-70234
Identifier Type: -
Identifier Source: secondary_id
IMF-DZ-110413
Identifier Type: -
Identifier Source: org_study_id