Clinical trial NCT03476954: Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
Official title: Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz
timeFrame: Baseline
measure: Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia
timeFrame: Baseline
Secondary outcomes:
measure: Change in MFV as measured by transcranial doppler (TCD), during RI
timeFrame: Baseline
measure: Change in mean arterial pressure (MAP,) during RI
timeFrame: Baseline
measure: Change in end-tidal carbon dioxide (CO2), during RI
timeFrame: Baseline
measure: Time to maximum CBF effect after the introduction of RI
timeFrame: Baseline
measure: Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge)
timeFrame: Baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References: