Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)

Study Overview
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Brief Summary
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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.

Official Title
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Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)

Conditions
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Stroke

Intervention / Treatment
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* Other: Respiratory Impedance (RI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Ability and willingness to sign informed consent by patient or legally acceptable surrogate decision maker Acute ischemic stroke within 72 hours of study enrollment Imaging or examination confirming unilateral frontal lobe involvement in the stroke Exclusion Criteria: Hemorrhagic conversion of ischemic infarct History or presence of congestive heart failure, as defined by any of the following: Any preceding diagnosis of congestive heart failure as per patient report or medical record Report of moderate or severe systolic or diastolic dysfunction on prior Reduced ejection fraction, <50%, on prior echocardiogram Jugular venous pulsations >10 cm Pulmonary edema on chest radiography Of note, an echocardiogram is not required prior to study enrollment. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Respiratory Impedance (RI)|A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |