跳至主要内容
临床试验/NCT06143384
NCT06143384尚未招募不适用

Benefits of Telemonitoring in Home Mechanical Ventilation by the Use of a Simple and Intuitive Algorithm

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Compliance to the treatment

研究概览

简要总结

Multicentric, observational and longitudinal prospective evaluation of build-in-software data telemonitoring of home ventilators in patients using Home Mechanical Ventilation in Belgium.

详细描述

OBJECTIVES : Use of a decisional algorithm (developed by La Citadelle/Liège) to assess Telemonitoring (AirView type, ResMed) of data in the ventilators of patients using Home Mechanical Ventilation (HMV), and registered in the Belgian agreement for HMV at 1/ the Citadelle hospital in Liège and 2/HUB-Erasme, Brussels, Belgium.

BACKGROUND: HMV initiated in the hospital is used at home. Patients who benefit from HMV present significant functional limitations of cardio-respiratory, neurological and/or physical origin. Such limitations compromise the ability of patients to travel to the referring hospital. As a result, good treatment follow-up is difficult to assess both from quantity and quality points of view. This is why Telemonitoring systems have been developed to access ventilator build-in-software data at through dedicated online systems. In other words, data from devices operating at home can be sent to the hospital and analyzed in real time by professionnals in the hospital. This project aims to evaluate the impact of Telemonitoring ventilator's data on the quality of HMV-monitoring in patients living and using HMV at home.

METHODS: A one-year multicentric, observational, longitudinal and prospective evaluation of build-in-software data telemonitoring of home ventilators in patients using HMV in Belgium. The two Belgian hospitals will each follow 10 patients for one year (2024). The data from the ventilator as well as the actions to be taken in response to Airview Telemonitoring alerts will be carried out using a decision-making algorithm created by the Citadelle Hospital in Liège.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
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

  • •All patients starting HMV in 2024, followed up in 1/ Liège or 2/ Brussels, and using devices from the ResMed company (Astral 150 ou Lumis 150).

排除标准

  • •Individuals refusing to sign the consent form
  • •Presence of acute pathology requiring hospitalization and close monitoring of ventilation
  • •Patients using a tracheostomy

结局指标

主要结局

Compliance to the treatment

时间窗: T4: Mean value during nights 174-180 (outpatient)

Hours of use of HMV/24h

Leaks

时间窗: T4: Median value during nights 174-180 (outpatient)

Unintentional leaks inform about undesirable leakage around the mask (bad sealing) or patients mouth leakage.

AHI index

时间窗: T4: Median value during nights 174-180 (outpatient)

The apnea-hypopnea index (AHI) informs about obstructive and apneic events during HMV.

次要结局

  • Inconfort score(T4 : Score after nights 174-180 (outpatient))
  • Algorithm Score(T4 : Score after night 2 (outpatient))

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michel Toussaint

Coordinator Center for Home Mechanical Ventilation

Erasme University Hospital

研究点 (1)

Loading locations...

相似试验