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临床试验/NCT02652559
NCT02652559已完成不适用

Treatment of Chronic Respiratory Failure in COPD Patients With Non-invasive Ventilation: Starting at Home and Selecting the Right Patient

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
主要终点
Change in daytime PaCO2

研究概览

简要总结

Rationale:

Application of long-term non-invasive ventilation (NIV) in stable chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve survival and quality of life when applied with sufficiently high inspiratory pressures and adequate backup breathing frequencies (so called high-intensity NIV). However, for a broader implementation of this therapy in a potentially large group of patients, important issues have to be solved. First, the initiation of high-intensity NIV, currently performed in the hospital, is often time-consuming, expensive and inconvenient for patients. Secondly, although clinicians recognise that not all patients benefit, it is not known which factors predict a positive response.

Objectives:

  1. To investigate whether home initiation of chronic NIV in stable COPD patients with CHRF is non-inferior to inpatient initiation.
  2. To investigate predictors of a favourable response to chronic NIV in COPD patients with CHRF.

Study design:

The study is 1:1 two-arm parallel group randomised controlled trial comparing the usual inpatient NIV initiation to home initiation.

Study population: Seventy-two COPD patients with a NIV indication (COPD GOLD stage III or IV; partial arterial carbon dioxide pressure (PaCO2) > 6.0 kPa in stable condition, i.e. no COPD exacerbation for 4 weeks and a pH > 7.35), a sufficient social network at home, without severe cardiac comorbidities, will be included.

Intervention: Home initiation of NIV will be compared with standard in-hospital initiation. NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be adjusted with the use of telemedicine.

Main study parameters/endpoints:

  1. To investigate non-inferiority of home initiation, the change in arterial carbon dioxide pressure after 3 months treatment will be the primary outcome. Secondary outcomes are safety, change in lung function, health-related quality of life (HRQoL) and costs.
  2. To investigate predictors of a favourable response, patient demographics, and baseline data on lung function as well as measures of respiratory muscle activity, arterial blood gases, comorbidities, inflammatory blood markers and anxiety and depressions scores will be collected of all patients.

详细描述

COPD is a chronic disease with high mortality and morbidity worldwide. Patients with end-stage COPD frequently develop CHRF associated with end-of-life. In that stage of disease, treatment options are limited.

Long-term nocturnal NIV has been applied in patients with chronic alveolar hypoventilation for decades. While there is no doubt that applying chronic nocturnal NIV improves outcomes in patients with restrictive and neuromuscular diseases, the evidence in COPD patients has long been controversial. At the HMV centre Groningen, the majority of patients treated with NIV therefore still concerns patients with neuromuscular diseases.

Initial trials investigating chronic NIV in COPD showed no relevant benefits, neither in terms of improvement in gas exchange nor in improvements in patient-centred outcomes as HRQoL.However, most of these trials used low inspiratory pressures so that improvement of alveolar hypoventilation was not or only partially achieved. Consequently, little improvement in clinical outcomes could be expected.

More than 10 years ago, the concept of high-intensity NIV in COPD was introduced. By applying higher inspiratory pressures and breathing frequencies aimed at a more controlled form of ventilation and improvement in gas exchange, clinically relevant improvements in HRQoL and lung function were observed, without undue loss of patient comfort. Recently, a German group conclusively showed that high-intensity NIV improves survival in severe COPD patients with CHRF. These positive results with high-intensity NIV have changed our view towards the use of chronic NIV in stable COPD. Nowadays, the investigators believe that the evidence for long-term nocturnal NIV is convincing and justifies the application of this therapy in patients with severe stable COPD patients with CHRF. Nevertheless, for a broader implementation of this treatment in a potentially large group of severe COPD patients, important issues have to be solved.

First, the current inpatient NIV initiation process has to be reconsidered, which despite tight titration based on arterial blood gases, does not always lead to good patient compliance, is inconvenient for patients and is expensive. While it might be thought that high-intensity NIV necessitates inpatient titration to gain adequate reversal of hypoventilation, different in hospital set ups of NIV initiation (on a general ward, medium care unit or on an intensive care unit), with different ways of titration (guided by transcutaneous carbon dioxide (PtCO2) or arterial blood gases (PaCO2)), have not resulted in different outcomes or a different compliance at the long-term. Also, these inpatient options are expensive as initiation of NIV in COPD routinely requires 5-14 days. Recently, our group of the HMV centre Groningen has shown that, in patients with neuromuscular and restrictive thoracic diseases, initiation of NIV can safely be performed at home. Initiation of NIV at home was preferred by the patients, was equally effective and saved costs compared to inpatient initiation. Importantly, COPD patients have been excluded in this randomised controlled trial (RCT), as at the start of that study chronic NIV in COPD was not considered a regular standard treatment option in the Netherlands. Furthermore, initiation of NIV in COPD patients at that time was thought to be probably too difficult to be performed at home, because high-intensity NIV is needed in this patient group to improve outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • 未提供

排除标准

  • Instable severe cardiac comorbidities (left ventricular ejection fraction below 45%, instable angina pectoris complaints)
  • Patients admitted to a nursing home

研究组 & 干预措施

Home initiation

Experimental

Home initiation of long-term NIV will be compared with standard in-hospital initiation. NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be adjusted with the use of telemedicine.

干预措施: Transcutaneous measurements of PCO2 (Device)

Home initiation

Experimental

Home initiation of long-term NIV will be compared with standard in-hospital initiation. NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be adjusted with the use of telemedicine.

干预措施: Telemonitoring (Device)

Home initiation

Experimental

Home initiation of long-term NIV will be compared with standard in-hospital initiation. NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be adjusted with the use of telemedicine.

干预措施: EMG (Device)

Home initiation

Experimental

Home initiation of long-term NIV will be compared with standard in-hospital initiation. NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be adjusted with the use of telemedicine.

干预措施: Home initiation of NIV (Other)

Inhospital initiation

Active Comparator

Inhospital initiation of NIV is standard care and in the study will be set as the control arm.

干预措施: Transcutaneous measurements of PCO2 (Device)

Inhospital initiation

Active Comparator

Inhospital initiation of NIV is standard care and in the study will be set as the control arm.

干预措施: EMG (Device)

Inhospital initiation

Active Comparator

Inhospital initiation of NIV is standard care and in the study will be set as the control arm.

干预措施: Inhospital initiation of NIV (Other)

结局指标

主要结局

Change in daytime PaCO2

时间窗: Baseline, 6 months

An arterial function will be performed during spontaneous breathing without oxygen after 6 months.

次要结局

  • Change in health-related quality of life (HRQoL)(Baseline, 6 months)
  • Incremental cost-utility ratio(Baseline, 6 months)
  • Number of participants with treatment-related adverse events(Baseline, 3 months and 6 months)
  • Compliance(Baseline, 3 months and 6 months)
  • Change in exercise tolerance(Baseline, 6 months)
  • Change in FEV1(Baseline, 6 months)
  • Change in hyperinflation(Baseline, 6 months)
  • Change in diffusion capacity(Baseline, 6 months)
  • Change in PaCO2(Baseline, 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marieke Duiverman

Dr.

University Medical Center Groningen

研究点 (2)

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