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Continuous Positive Airway Pressure Ventilation After Acute Ischemic Stroke

This study has been completed.
Sponsor:
Collaborators:
New Health Sciences, Inc.
Rubel GmbH, Heiligenhaus, Germany
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00151177
First received: September 7, 2005
Last updated: November 23, 2010
Last verified: April 2008
  Purpose

More than half of all stroke patients have sleep apneas in the acute phase after stroke. Sleep apneas may be associated with higher degrees of disability three months after stroke due to numerous factors associated with sleep apneas such as persistent hypertension, cardiac arrhythmias, and clotting disorders.

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.


Condition Intervention Phase
Brain Infarction
Device: non-invasive continuous positive airway pressure ventilation
Device: CPAP-treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Efficacy Study of Early Continuous Positive Airway Pressure Ventilation in Patients With Acute Ischemic Stroke

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Primary endpoint is to test the feasibility of early non-invasive CPAP ventilation in acute stroke patients

Secondary Outcome Measures:
  • Size of brain infarction on diffusion weighted MRI imaging at day 10 after symptom onset
  • Disability measured by the modified Rankin scale after three months

Estimated Enrollment: 100
Study Start Date: April 2005
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
treatment with three nights of CPAP ventilation starting the first night of admission
Device: non-invasive continuous positive airway pressure ventilation Device: CPAP-treatment
night time CPAP-mask ventilation
No Intervention: B
usual Stroke Unit care
Device: CPAP-treatment
night time CPAP-mask ventilation

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • AGE 18-85 years,
  • NIH-SS 2-20 points,
  • NIH-SS subitem 1a <=1.

Exclusion criteria:

  • Modified Rankin Scale Score >=2 on admission
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151177

Locations
Germany
University_Hospital_Muenster
Muenster, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
New Health Sciences, Inc.
Rubel GmbH, Heiligenhaus, Germany
Investigators
Principal Investigator: Darius G Nabavi, MD University Hospital Muenster
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. M. Ritter, University_Hospital_Muenster
ClinicalTrials.gov Identifier: NCT00151177     History of Changes
Other Study ID Numbers: IMF-DZ-110413, NHSi2005-iCPAPAPNEASTROKE-001, UKM-SL-70234
Study First Received: September 7, 2005
Last Updated: November 23, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
ischemic stroke
CPAP ventilation

Additional relevant MeSH terms:
Brain Infarction
Infarction
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Stroke
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014