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

NCT03476954 | Completed

• 1 other identifier: 824558
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Respiratory impedance monitoring session

EXPERIMENTAL

Other: Respiratory Impedance (RI)

Interventions

Respiratory Impedance (RI) OTHER

A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration.

Respiratory impedance monitoring session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 26, 2018
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)