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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Respiratory Impedance (RI)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respiratory impedance monitoring session	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?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 824558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No