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This is a non-randomized phase 2 study designed to asses the mean flow velocity (MFV) and cerebral blood flow (CBF) response to non-invasive respiratory impedance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory impedance monitoring session | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Impedance (RI) | Other | A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz | Baseline | |
| Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MFV as measured by transcranial doppler (TCD), during RI | Baseline | |
| Change in mean arterial pressure (MAP,) during RI | Baseline | |
| Change in end-tidal carbon dioxide (CO2), during RI |
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Inclusion Criteria:
Exclusion Criteria:
Hemorrhagic conversion of ischemic infarct
History or presence of congestive heart failure, as defined by any of the following:
History or presence of cardiomyopathy, as per medical record, patient report, or prior echocardiogram
History or presence of pneumothorax or hemothorax
History or presence of COPD
History of current use of home oxygen
Presence of pneumonia, as clinically determined by the primary medical team after admission chest radiography
Age < 18 years
Skull defect that would interfere with CBF monitoring
Pregnancy (urine or serum testing will required prior to enrollment of any pre-menopausal women)
Structural brain lesion, including known primary tumor, metastatic tumor, or vascular malformation
Prior neurosurgical procedure
Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline |
| Time to maximum CBF effect after the introduction of RI | Baseline |
| Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge) | Baseline |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |