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临床试验/NCT04932811
NCT04932811进行中(未招募)不适用

The Lung Microbiome in Patients With Emphysema and Chronic Obstructive Lung Disease Treated With Endobronchial Valves: Complications and Prognosis

Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
2
主要终点
Number of pulmonary infections

研究概览

简要总结

Lung emphysema is an incurable disease and is often associated with chronic obstructive pulmonary disease (COPD). Dyspnea is the main, debilitating symptom and is relieved by inhaled bronchodilators and rehabilitation. However, a substantial number of patients continue to suffer from dyspnea, and among these, many patients have severe hyperinflated lungs due to emphysema. For selected patients, lung transplantation or lung volume reduction by surgical removal (LVRS) of the most emphysematous parts of the lungs can improve symptoms and survival. However, LVRS has a relatively large risk of adverse events, and therefore not all patients are suitable for surgery. An alternative to LVRS is bronchial lung volume reduction with endobronchial valves (EBV), where one-way valves are inserted in the bronchial system. It has emerged as a valid treatment option, with reduction of hyperinflation and increased pulmonary function, quality of life, and exercise capacity.

The normal lung is colonized with several types of bacteria, and together these are called the microbiome. Some bacteria are potentially beneficial, while others are potentially harmful. After the insertion of EBVs, some patients develop chronic infections. The hypothesis is that the microbiome can affect the risk of chronic infection, and therefore the objective of this study is to assess the microbiome during the insertion of the EBVs and afterwards observe which patients develop chronic infection and whether these patients are harboring specific bacterial species.

详细描述

The objective of this study is primarily to investigate the effect of the lung microbiome on outcomes and morbidity after EBV treatment. Second, to investigate the evolution of the lung microbiome in patients later requiring valve removal or clean-up.

Before the insertion of the EBV, during the procedure, the patient will undergo a bronchoalveolar lavage (BAL). BAL fluid will be used for bacterial profiling through 16S ribosomal analysis and conventional bacterial culture. The number of infections and the need for clean-up or valve removal will be registered during the following 24 months, during which the patient follows the ordinary follow-up programme. As a secondary part of the study, during potential clean-up or valve removal, the removed material will again undergo 16S ribosomal analysis and culture to investigate shifts in the microbiome.

研究设计

研究类型
Observational
观察模型
Cohort
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
否

入选标准

  • •COPD patients with emphysema selected for EBV treatment by a multidiciplinary team, independent of this study.
  • •Written informed consent

排除标准

  • •- Intake of oral antibiotics within 1 month before the procedure. Patients receiving prophylactic long-term treatment with antibiotics can be included.

研究组 & 干预措施

Patients

COPD patients treated with endobronchial valves

干预措施: Endobronchial valve treatment (Procedure)

结局指标

主要结局

Number of pulmonary infections

时间窗: 2 years

Number and severity of pulmonary infection after surgery

Frequency of Valve dysfunction

时间窗: 2 years

Dysfunction of valves requiring clean up

Diversity of Microbiome

时间窗: During surgery

Diversity of microbiome

Valve dysfunction

时间窗: 2 years

Dysfunction of valves requiring clean up

Microbiome

时间窗: During surgery

Microbiome in bronchioalveolar lavage

Pulmonary infection

时间窗: 2 years

Number and severity of pulmonary infection after surgery

次要结局

  • Frequency of formation of atelectasis(2 years)
  • Formation of atelectasis(2 years)

研究者

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

Kirstine Hermann

Principal Investigator

Aarhus University Hospital

研究点 (2)

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