跳至主要内容
临床试验/NCT06178068
NCT06178068尚未招募不适用

Comparison of Bronchodilator Treatment Practices in Group E COPD Patients

Ataturk University0 个研究点目标入组 39 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
39
主要终点
Evaluation of the change in respiratory function test parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests

研究概览

简要总结

COPD is a heterogeneous condition caused by airway (bronchitis/bronchiolitis) or alveolar (emphysema) abnormality, changes with chronic respiratory changes (dyspnea, dyspnoea, phlegm). It is characterized by persistent and frequently progressive airway obstruction. In COPD, which progresses with high mortality, non-pharmacological treatments are applied, as well as pharmacological treatments. They have an essential place in slowing down the progressive course of this treatment. However, despite the treatment administered to COPD patients, outdoor weather conditions, improper use of inhaler treatments, or comorbidities may cause acute exacerbation of COPD.

Dry air nebulizer devices use dry air from the central system in hospitals. This system, which converts bronchodilator drugs into nebulizers by creating high currents, works like classical nebulizers without an electrical system and can have a higher flow rate than jet nebulizer devices. This procedure, which can be applied to COPD patients without giving high-flow oxygen, prevents carbon dioxide retention. There is no study in the literature comparing the bronchodilator effectiveness of dry air, classical nebulizer, and jet nebulizer, and the investigators aimed to compare the efficacy of these three treatment modalities in our study.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Group E COPD patients

排除标准

  • •Recent MI
  • •Pulmonary embolism
  • •Cerebral aneurysm
  • •Active hemoptysis
  • •Pneumothorax
  • •Nausea, vomiting
  • •Recent thorax, abdominal, and eye surgery were identified in the patients before the pulmonary function test and were not included in the study.
  • •Mental retardation
  • •Pneumonia with acute exacerbation of COPD
  • •Patients with pulmonary edema due to congestive heart failure
  • •Patients with interstitial lung disease along with COPD

研究组 & 干预措施

Group 1; jet nebulizer group

Active Comparator

The Respirox® RNEB-18 device was used for the bronchodilator treatment given before the randomization of the patients and for the maintenance bronchodilator treatment given in Group 1 patients. After calibrating the device, it was determined that it performed nebulization with a flow of 6 lt/min.

干预措施: Comparison of bronchodilator effectiveness of nebulizer therapy devices (Device)

Group 2; dry air nebulizer group

Active Comparator

In Group 2 patients, a HAVELSAN® EHSİM brand nebulizer produced in our country, compatible with the central system of our hospital, was used as a dry air nebulizer.

干预措施: Comparison of bronchodilator effectiveness of nebulizer therapy devices (Device)

Group 3; Classic nebülizer group

Active Comparator

For classical nebulizer treatment in Group 3 patients, a nebulizer device compatible with our hospital's central oxygen system was used.

干预措施: Comparison of bronchodilator effectiveness of nebulizer therapy devices (Device)

结局指标

主要结局

Evaluation of the change in respiratory function test parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests

时间窗: 5 days

Measurement of % change in FVC, FEV1, RV, TLC level

Evaluation of the change in arterial blood gas parameters after 5 days of nebulizer treatment applications.randomization on respiratory function tests

时间窗: 5 days

Saturation %, measurement of change in partial oxygen and partial carbon dioxide levels in mm_Hg

次要结局

未报告次要终点

研究者

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

Bugra Kerget

Associate professor

Ataturk University

相似试验