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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Respiratory Impedance (RI)

• Registration Number: NCT03476954
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Respiratory impedance monitoring session	Respiratory Impedance (RI)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States