A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Quantitative Pulmonary Function Testing in ALS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Correlation of EIT and PFT measures
研究概览
简要总结
This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients. The study will enroll patients with ALS in one cohort and healthy volunteers in a second cohort that will both undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure.
详细描述
This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients.
For both Cohort I and II, subject participation will require two visits (initial and 3-4 month follow up), which are expected to last approximately 30 minutes. Subjects will undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure. The actual EIT imaging will last for 10 to 15 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALS patients able to perform PFT.
- •ALS patients recommended for PFT.
- •Subjects capable of giving written informed consent.
- •Adult, age ≥ 18 years old.
排除标准
- •Serious psychiatric illnesses.
- •Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
- •Skin lesions at chest belt placement sites.
- •Pregnant women.
- •Patients with primary lung disease, at the discretion of the Investigator.
- •Subjects capable of giving written informed consent;
- •Subjects capable of performing a PFT;
- •Adult, age ≥ 18 years old 10.2.2 Exclusion Criteria
- •Serious psychiatric illnesses.
- •Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
- •Skin lesions at chest belt placement sites.
- •Pregnant women.
- •Subjects with primary lung disease, at the discretion of the Investigator.
结局指标
主要结局
Correlation of EIT and PFT measures
时间窗: Through study completion, an average of 3 months
A correlation coefficient (-1 to +1) will be used
次要结局
- Assessing differences in lung function images in healthy versus ALS cohorts as generated with EIT(Through study completion, an average of 3 months)
研究者
Seward Rutkove
Chairman, Department of Neurology
Beth Israel Deaconess Medical Center