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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respiratory Impedance (RI)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of the University of Pennsylvania

Outcomes

Primary Outcome Measures

Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz
Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia

Secondary Outcome Measures

Change in MFV as measured by transcranial doppler (TCD), during RI
Change in mean arterial pressure (MAP,) during RI
Change in end-tidal carbon dioxide (CO2), during RI
Time to maximum CBF effect after the introduction of RI
Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge)

Full Information

First Posted
March 19, 2018
Last Updated
March 19, 2018
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03476954
Brief Title
Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
Acronym
PERI-Stroke
Official Title
Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Respiratory Impedance (RI)
Intervention Description
A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration.
Primary Outcome Measure Information:
Title
Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz
Time Frame
Baseline
Title
Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in MFV as measured by transcranial doppler (TCD), during RI
Time Frame
Baseline
Title
Change in mean arterial pressure (MAP,) during RI
Time Frame
Baseline
Title
Change in end-tidal carbon dioxide (CO2), during RI
Time Frame
Baseline
Title
Time to maximum CBF effect after the introduction of RI
Time Frame
Baseline
Title
Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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) Structural brain lesion, including known primary tumor, metastatic tumor, or vascular malformation Prior neurosurgical procedure Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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