Noninvasive Neurostimulation of the Vagus Nerve With the AlphaCore System for the Relief of Acute Bronchoconstriction Due to Asthma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 10
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The objective of this feasibility research study is to gather preliminary clinical data regarding the safety and potential clinical benefit of noninvasive neurostimulation of the vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to asthma.
详细描述
The purpose of the study was to collect initial safety and efficacy information of use of the AlphaCore System by clinicians in an emergency setting as an adjunctive treatment to standard of care for the relief of acute bronchoconstriction. After consent was obtained and screening completed, subjects were stimulated two times, 30 minutes apart, for 90 seconds each. Subjects were assessed prior to and immediately post the first stimulation and at 15, 30, 60, and 90 minutes; follow was also conducted at day 7 and day 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is between the ages of 18 and 70 years.
- •Has been admitted to an emergency care facility with a working diagnosis of bronchoconstriction due to asthma.
- •Has an FEV1<60% predicted.
- •Is available and willing to return for an office visit at 7 days and participate in a 30-day telephone call from time of discharge from the ED.
- •Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.
排除标准
- •Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity due to irreversible narrowing of the airways.
- •Is at risk of imminent respiratory collapse:
- •Lung Function: FEV1 < 25% predicted
- •Signs and symptoms of extreme respiratory distress at rest, such as accessory muscle use, chest retraction
- •Consciousness State: Drowsy, confused
- •Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc).
- •Has an abscess or other infection or lesion (including lymphadenopathy) at the therapy head placement site.
- •Has known or suspected atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
- •Has suspected or confirmed sepsis.
- •Has a clinically significant irregular heart rate or rhythm.
- •Clinically significant changes in blood pressure or is receiving pressors to maintain blood pressure.
- •Is currently implanted with an 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.
- •Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- •Has been implanted with metal cervical spine hardware.
- •Has a condition that would interfere with VAS Dyspnea self-assessment.
- •Is pregnant.
- •Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- •Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 30 days
Subjects were assessed for adverse events for the duration of procedure. Subjects were also seen at 7 days and had a phone call at 30 days from the date of the stimulation procedure.
次要结局
- Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes(30 minutes)
- Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes(30 minutes)
- Time to Discharge From the Emergency Department(Duration of stay in emergency room - up to approximately 6 hours.)
- Number of Participants With Requirement for Concomitant Medications(Duration of stay in emergency room, up to approximately 6 hours)