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

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03476954
Collaborator
(none)
20
Enrollment
1
Location
5.9
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Respiratory Impedance (RI)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Outcome Measures

Primary Outcome Measures

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

  2. Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia [Baseline]

Secondary Outcome Measures

  1. Change in MFV as measured by transcranial doppler (TCD), during RI [Baseline]

  2. Change in mean arterial pressure (MAP,) during RI [Baseline]

  3. Change in end-tidal carbon dioxide (CO2), during RI [Baseline]

  4. Time to maximum CBF effect after the introduction of RI [Baseline]

  5. Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge) [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  3. Any preceding diagnosis of congestive heart failure as per patient report or medical record

  4. Report of moderate or severe systolic or diastolic dysfunction on prior

  5. Reduced ejection fraction, <50%, on prior echocardiogram

  6. Jugular venous pulsations >10 cm

  7. Pulmonary edema on chest radiography Of note, an echocardiogram is not required prior to study enrollment.

  8. History or presence of cardiomyopathy, as per medical record, patient report, or prior echocardiogram

  9. History or presence of pneumothorax or hemothorax

  10. History or presence of COPD

  11. History of current use of home oxygen

  12. Presence of pneumonia, as clinically determined by the primary medical team after admission chest radiography

  13. Age < 18 years

  14. Skull defect that would interfere with CBF monitoring

  15. Pregnancy (urine or serum testing will required prior to enrollment of any pre-menopausal women)

  16. Structural brain lesion, including known primary tumor, metastatic tumor, or vascular malformation

  17. Prior neurosurgical procedure

  18. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steven Messe, Associate Professor of Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03476954
Other Study ID Numbers:
  • 824558
First Posted:
Mar 26, 2018
Last Update Posted:
Mar 26, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Mar 26, 2018