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临床试验/NCT06702072
NCT06702072尚未招募不适用

Change in Task-related Oxygen Uptake After Bronchoscopic Lung Volume Reduction With Endobronchial Valves

Dirk-Jan Slebos1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5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
Task-related oxygen uptake

研究概览

简要总结

Rationale: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). It is known that patients with COPD frequently experience problems during ADL, which can lead to avoidance of or care dependency for performing certain tasks and have a significant social impact on their lives.

Patients report that it is easier to perform ADLs after EBV treatment. Previously it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs has never been investigated before.

Potentially, EBV treatment could improve the metabolic load and consequently symptom perception, thus enhancing the execution of ADLs, which is an important patient-centred outcome. However, this has not been investigated so far.

Objective: To investigate the change in exercise physiology during daily activities after EBV treatment.

Study design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.

Study population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.

Intervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.

详细描述

Rationale: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). The 6MWT is conducted under laboratory conditions, which weakly correspond to activities of daily living (ADL). It is known that patients with COPD frequently experience problems during ADL, which can lead to avoidance of or care dependency for performing certain tasks and have a significant social impact on their lives.

Patients report that it is easier to perform ADLs after EBV treatment. Previously, it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs was not investigated before. This could be measured with a mobile oxygen device which can measure oxygen uptake (VO2) and carbon dioxide production (VCO2) under more functional conditions and thus measure the metabolic load of these activities.

Potentially, EBV treatment could improve the metabolic load and consequently symptom perception, thus enhancing the execution of ADLs, which is an important patient-centred outcome. However, this has not been investigated so far.

Objective: To investigate the change in exercise physiology during daily activities after EBV treatment.

Study design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient is scheduled for a bronchoscopic lung volume treatment using Pulmonx Zephyr Endobronchial Valves;
  • Patient read, understood and signed the Informed Consent Form.

排除标准

  • Patients who cannot perform ADL activities without the use of Long Term Oxygen Therapy (LTOT).

结局指标

主要结局

Task-related oxygen uptake

时间窗: 6 months follow up

The change between baseline and 6 months of follow up after EBV treatment in task-related oxygen uptake (VO2) during a set-up daily life activity trail.

次要结局

未报告次要终点

研究者

发起方
Dirk-Jan Slebos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dirk-Jan Slebos

MD PhD

University Medical Center Groningen

研究点 (1)

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