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

Stroke Clinical Trial

— PERI-Stroke  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476954
• Other study ID #: 824558
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Respiratory Impedance (RI)
A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz		Baseline
Primary	Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia		Baseline
Secondary	Change in MFV as measured by transcranial doppler (TCD), during RI		Baseline
Secondary	Change in mean arterial pressure (MAP,) during RI		Baseline
Secondary	Change in end-tidal carbon dioxide (CO2), during RI		Baseline
Secondary	Time to maximum CBF effect after the introduction of RI		Baseline
Secondary	Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge)		Baseline