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

University of Pennsylvania1 site in 1 country20 target enrollmentSeptember 2016

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: University of Pennsylvania
Enrollment: 20
Locations: 1
Primary Endpoint: Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

March 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Principal Investigator

Steven Messe

Associate Professor of Neurology

University of Pennsylvania

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz

Time Frame: Baseline

Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia

Time Frame: Baseline

Secondary Outcomes

Change in end-tidal carbon dioxide (CO2), during RI(Baseline)
Change in mean arterial pressure (MAP,) 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 MFV as measured by transcranial doppler (TCD), during RI(Baseline)