NCT03476954已完成不适用
Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Respiratory impedance monitoring session
Experimental
干预措施: Respiratory Impedance (RI) (Other)
结局指标
主要结局
Change in CBF that occurs during RI, as measured by diffuse correlation spectroscopy (DCS) with a sampling frequency of 5 Hz
时间窗: Baseline
Reports of any of the following: shortness of breath, chest pain, fatigue, or hypoxia
时间窗: Baseline
次要结局
- 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)
研究者
Steven Messe
Associate Professor of Neurology
University of Pennsylvania
研究点 (2)
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