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Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm

2021年3月2日 更新者:ResMed

Adjustment of Non-invasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Ventilatory Failure Using Automated End-expiratory Pressure (AutoEEP) Algorithm

The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure. For this purpose, The investigators will study different groups of patients, including those with obstructive and restrictive ventilatory defect, and obstructive sleep apnoea, non-naive to conventional bi-level positive airways pressure therapy.

研究概览

详细说明

Persisting ventilatory failure associated with chronic obstructive pulmonary disease (COPD), obesity-hypoventilation-syndrome, sleep apnoea or neuromuscular disease is increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV).

Optimal settings of non-invasive ventilation are usually titrated manually and require time and expertise. The development of systems lead to automated analysis and development of algorithms to adjust ventilators. However, there is a paucity of optimal algorithms, particularly the problem of upper airway obstruction. Therefore, the central aim of this study is to develop the automated setting of an end-expiratory positive airway pressure (EPAP), because upper airway obstruction is relatively common in this group of patients. We hypothesise that an automated end-expiratory airway pressure (AutoEEP) adjusting algorithm could overcome these problems and further optimise and adjust ventilator settings. Using non-invasive ventilation in patients with hypercapnic ventilatory failure, awake and asleep, we will measure physiological outcome parameters and apply an AutoEEP algorithm, comparing it against usual care.

研究类型

介入性

注册 (实际的)

21

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Essen、德国、45239
        • Abteilung Pneumologie - Universitätsklinik, Ruhrlandklinik

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects will be patients not naive to noninvasive ventilation, and being so treated for any form of hypercapnic ventilatory failure.
  • Previously stabilised on bilevel noninvasive pressure support ventilation.
  • Both genders, age <75years.
  • Previously shown to have a requirement for an EEP above cm H2O in order to maintain upper airway patency, or those in whom such a raised EEP would be expected, e.g. obese patients.
  • Patients also known to have adequate airway patency at an EEP of 4 to 5 cm H2O will be included to ensure specificity of the algorithm.

Exclusion Criteria:

  • Acute critical illness (e.g. acute coronary syndrome, stroke)
  • Serious anatomical variations of nose, sinuses, pharynx or oesophagus.
  • Any condition at risk of oesophageal bleeding (e.g. oesophageal varices, gastric ulcer, etc.)
  • Age >75 years
  • Pregnancy
  • Epilepsy
  • Psychiatric disorders that could possibly influence the study
  • Any kind of addiction
  • Insufficient knowledge of the language
  • Noninvasive ventilation otherwise contraindicated

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:AutoVPAP with addition of AutoEPAP
This arm will receive conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure. Patients randomised to this group will then receive the other treatment the following night.
Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.
Conventionally applied Expiratory Positive Airway Pressure (EPAP)
有源比较器:AutoVPAP without addition of AutoEPAP
This arm will receive conventionally applied Expiratory Positive Airway Pressure. Patients randomised to this group will then receive the other treatment the following night.
Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.
Conventionally applied Expiratory Positive Airway Pressure (EPAP)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI)
大体时间:On completion of each consecutive night of polysomnography.
The AHI is a count of the number of pauses during sleep a person experiences. The total number of apneas/ hypopneas (sleep pauses) are divided by the total sleep time to get an index for that night
On completion of each consecutive night of polysomnography.

次要结果测量

结果测量
措施说明
大体时间
Mean SpO2
大体时间:On completion of each night of 2 consecutive nights polysomnography.
During sleep, pulse oximetery is recorded through a sensor on the participants finger
On completion of each night of 2 consecutive nights polysomnography.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Helmut Teschler, Dr. med.、Abteilung Pneumologie - Universitätsklinik, Essen, Germany

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年7月1日

初级完成 (实际的)

2015年2月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2011年7月25日

首先提交符合 QC 标准的

2011年7月26日

首次发布 (估计)

2011年7月27日

研究记录更新

最后更新发布 (实际的)

2021年3月26日

上次提交的符合 QC 标准的更新

2021年3月2日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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