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临床试验/NCT05495256
NCT05495256已完成不适用

Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.

Pulmonary Critical Care Associates of Baltimore1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年5月1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
74
试验地点
1
主要终点
Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device

研究概览

简要总结

To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique.

详细描述

Good metered dose inhaler (MDI) technique is described as sitting or standing upright with the head slightly tilted back, exhaling fully, and then inhaling slowly and deeply as you activate the MDI. Common mistakes include: not exhaling fully; not inhaling deeply enough; inhaling too quickly, and not activating the MDI at the proper time.

This study will use the Respimetrix device with placebo to assess a patient's inhaler technique, provide training to patients who demonstrate poor inhaler technique, and remotely track a subject's breathing ability over time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • •Patients 18 years of age or older
  • •Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients
  • •Patients must be willing and able to provide informed consent to participate in the the study.
  • •Patients must be able to use a metered dose inhaler

排除标准

  • •Contraindication to inhaler use
  • •Tracheostomy
  • •Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
  • •Unable to understand informed consent (e.g. non-English speakers)

研究组 & 干预措施

MDI Training

Other

All participants are led through the MDI training with the Respimetrix Device. Protocol is within groups design.

干预措施: Respimetrix (Device)

结局指标

主要结局

Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device

时间窗: 2 weeks

Measure actuation timing, flow rate and volume after intervention

次要结局

  • Describing baseline pressurized metered-dose inhaler (pMDI) technique(2 weeks)

研究者

发起方
Pulmonary Critical Care Associates of Baltimore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alan Schwartz

Principal Investigator

Pulmonary Critical Care Associates of Baltimore

研究点 (1)

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