Stroke
Conditions
Brief summary
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.
Interventions
OTHERRespiratory Impedance (RI)
A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Ability and willingness to sign informed consent by patient or legally acceptable surrogate decision maker 3. Acute ischemic stroke within 72 hours of study enrollment 4. Imaging or examination confirming unilateral frontal lobe involvement in the stroke
Exclusion criteria
1. Hemorrhagic conversion of ischemic infarct 2. History or presence of congestive heart failure, as defined by any of the following: 1. Any preceding diagnosis of congestive heart failure as per patient report or medical record 2. Report of moderate or severe systolic or diastolic dysfunction on prior 3. Reduced ejection fraction, \<50%, on prior echocardiogram 4. Jugular venous pulsations \>10 cm 5. Pulmonary edema on chest radiography Of note, an echocardiogram is not required prior to study enrollment. 3. History or presence of cardiomyopathy, as per medical record, patient report, or prior echocardiogram 4. History or presence of pneumothorax or hemothorax 5. History or presence of COPD 6. History of current use of home oxygen 7. Presence of pneumonia, as clinically determined by the primary medical team after admission chest radiography 8. Age \< 18 years 9. Skull defect that would interfere with CBF monitoring 10. Pregnancy (urine or serum testing will required prior to enrollment of any pre-menopausal women) 11. Structural brain lesion, including known primary tumor, metastatic tumor, or vascular malformation 12. Prior neurosurgical procedure 13. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change in end-tidal carbon dioxide (CO2), during RI | Baseline |
| Change in MFV as measured by transcranial doppler (TCD), during RI | Baseline |
| Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge) | Baseline |
| Time to maximum CBF effect after the introduction of RI | Baseline |
| Change in mean arterial pressure (MAP,) during RI | Baseline |
Countries
United States
Outcome results
None listed