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Completed

NCT Number: NCT03476954

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory Impedance (RI)

Other

A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration.

Primary outcomes

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

    Time frame: Baseline

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

    Time frame: Baseline

Secondary outcomes

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

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

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: PERI-Stroke

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2018
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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