StrokePERI-StrokeNCT03476954
Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
A study testing Respiratory Impedance (RI) in people with Stroke, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Respiratory Impedance (RI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- Respiratory Impedance (RI)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Impedance (RI)Other
A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory impedance monitoring session | Experimental | Not described Receives: Other: Respiratory Impedance (RI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz
Measured: Baseline
Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia
Measured: Baseline
Secondary outcomes (5)
Change in MFV as measured by transcranial doppler (TCD), during RI
Measured: Baseline
Change in mean arterial pressure (MAP,) during RI
Measured: Baseline
Change in end-tidal carbon dioxide (CO2), during RI
Measured: Baseline
Time to maximum CBF effect after the introduction of RI
Measured: Baseline
Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study startSep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Messe, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476954
- Sponsor's protocol ID
- 824558
- Acronym
- PERI-Stroke
- Status last verified
- Feb 2024
- First submitted
- 19 Mar 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
- ClinicalTrials.gov ID
- NCT03476954
- Acronym / sponsor ID
- PERI-Stroke / 824558
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory impedance monitoring session | Experimental | Other: Respiratory Impedance (RI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- Hemorrhagic conversion of ischemic infarct
- History or presence of congestive heart failure, as defined by any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Impedance (RI)A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration. | Other | Respiratory impedance monitoring session |
Primary outcome
Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz
Time frame: Baseline
Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia
Time frame: Baseline
5 secondary outcomes
Change in MFV as measured by transcranial doppler (TCD), during RI
Time frame: Baseline
Change in mean arterial pressure (MAP,) during RI
Time frame: Baseline
Change in end-tidal carbon dioxide (CO2), during RI
Time frame: Baseline
Time to maximum CBF effect after the introduction of RI
Time frame: Baseline
Change in National Institute of Health Stroke Scale (NIHSS) (admission vs discharge)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Impedance (RI) in people with Stroke, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.