Neurostimulation for the Relief of Acute Bronchoconstriction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- Safety- Number of Participants With Adverse Events
研究概览
简要总结
The goal of this study is to validate design for the Resolve™ Stimulator and Proximity Electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm that the electrical signal being delivered via this electrode rapidly counters bronchoconstriction and improves airway flow.
详细描述
The present study is to evaluate the safety of a new neurostimulator device, the Resolve Stimulator and Proximity Lead™, which comprises an external electrical signal generator coupled to temporary electrode that is percutaneously inserted in the neck.
Sponsor believes, based on animal testing data provided as well as consultations with physicians who regularly treat patients suffering from attacks of acute bronchoconstriction in ER and inpatient hospital settings, that this device could be used in the skilled care hospital setting to help rapidly relax the smooth muscle in the airway, relieving a clinically significant portion of the bronchoconstriction suffered by patients experiencing moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to restore the patient to his or her baseline respiration status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male / Female, Age 18-65
- •Subject declares a medical history of asthma or sufficient prior clinical experience/records exists to confirm the subject has received a diagnosis of bronchoconstriction
- •Completed >1 hrs of conventional breathing and related medication treatments without improvement in FEV1 to > 70% predicted
- •Able to give Informed Consent
排除标准
- •Scaring / abscess other problems with neck at electrode placement site
- •Known or suspected carotid artery disease (i.e. bruits or history of stenosis)
- •Suspected or confirmed coagulopathy
- •Suspected or confirmed sepsis
- •Irregular heart rate, rhythm
- •Receiving pressors to maintain blood pressure
- •Presently implanted electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
- •Allergy to local anesthetics used for placement of the lead
- •History of lung cancer, emphysema, chronic obstructive pulmonary disease, or other comorbidity that might otherwise compromise the expected air flow volumes in the lungs
- •At risk of imminent respiratory collapse
- •Lung Function: FEV1 < 40% predicted
- •Signs and Symptoms: Extreme symptoms at rest, accessory muscle use, chest retraction
- •Alert State: Drowsy, confused
- •Treatment with anti-cholinergic medications within 4 hours of enrollment
结局指标
主要结局
Safety- Number of Participants With Adverse Events
时间窗: 2 weeks
Safety- Number of participants that reported Adverse Events
次要结局
- Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).(60 minutes)