NCT03289715已完成不适用
Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation
Philips Electronics Nederland B.V. acting through Philips CTO organization1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年1月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- optimum comfortable amount of on-demand humidification
研究概览
简要总结
Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 of age; < 85 years of age
- •Participants with a neuromuscular disorder who:
- •Require 24 hour mechanical ventilation in some form through tracheostomy, mask or mouth piece
- •Can be ambulatory for at least a few hours during the day while using a heat and moisture exchange device (HME) or no humidification
- •Can part of the day use a heated pass-over humidification system while on their ventilator (overnight, for example).
- •Able to provide feedback/articulate via some form of communication
- •Patients using a Trilogy ventilator
- •Invasively ventilated patients that are willing to use a HME device on their way to participate in the study (from home to hospital).
- •Patients that are willing to participate and are able to consent and sign the informed consent form. (Patients with the functional capacity for medical decision-making).
排除标准
- •Clinically unstable, i.e.,
- •Acute respiratory failure
- •Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
- •Uncontrolled cardiac ischemia or arrhythmias
- •Any participant determined as inappropriate for the study by the Principal Investigator
- •Patients suffering from metastatic or terminal cancer
- •Patients lacking the functional capacity for medical decision-making.
研究组 & 干预措施
arm 1
Experimental
on demand humidification
干预措施: On Demand Humidification system Mark 2 (Device)
结局指标
主要结局
optimum comfortable amount of on-demand humidification
时间窗: 3 hours
questionnaire based on Borg Scale and Visual Analog scale
次要结局
未报告次要终点
研究者
研究点 (1)
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