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临床试验/NCT05130112
NCT05130112已完成不适用

Impact of Airways Function After Short-term Use of High-flow Nasal Cannula Gas Therapy Evaluated by Impulse Oscillometry Systems in Stable Chronic Obstructive Pulmonary Disease Patients

Fu Jen Catholic University Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年12月13日最近更新:
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
26
试验地点
1
主要终点
R5

研究概览

简要总结

In addition to pharmacological treatment, nonpharmacological treatment with high-flow nasal cannula (HFNC) may play a vital role in the treatment of patients with chronic obstructive pulmonary disease (COPD). The impulse oscillation system (IOS) is new noninvasive technique to measure the impedance of different portions of the airway with higher sensitivity than that of the conventional pulmonary function test (PFT). However, whether IOS is an appropriate technique to evaluate the efficacy of HFNC in improving the impedance of peripheral small airways in patients with COPD is unclear.

详细描述

Participants with stable COPD from the chest medicine outpatient department will be randomized into two groups receiving HFNC or nasal cannula (NC) for 10 min followed by a 4-week washout period and crossover alternatively. We used a novel analytical measurement technique, IOS, to detect the difference in airway impedance in the participants after the HFNC or NC interventions. All data, namely IOS parameters, transcutaneous partial pressure of carbon dioxide, peripheral oxygen saturation, body temperature, respiratory rate, pulse rate, blood pressure, and PFT results at the time of pre-HFNC, post-HFNC, pre-NC, and post-NC, were analysed using SPSS (version 25.0, IBM, Armonk, NY, USA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •age of 20 to 75 years old
  • •diagnosis of COPD made by pulmonologist (Kuo YL) if the patient had a long-term smoking or noxious gas exposure history, typical clinical manifestations, and airflow limitation with a postbronchodilator FEV1/FVC ratio of < 0.7 in spirometry,4 and
  • •provision of written informed consent.

排除标准

  • •severe and unstable comorbidities or active malignancy
  • •history of obstructive sleep apnoea syndrome
  • •COPD exacerbation within the 4 weeks prior
  • •current use of long-term oxygen therapy or noninvasive ventilation or use within the 6 weeks prior
  • •cognitive impairment or a psychiatric disorder
  • •pregnancy

研究组 & 干预措施

HFNC then NC

Experimental

High flow nasal cannula for 10 min (Period 1) and nasal cannula for 10 min (Period 2) after a 4-week washout period

干预措施: high flow nasal cannula and nasal cannula (Device)

NC then HFNC

Experimental

Nasal cannula for 10 min (Period 1) and high flow nasal cannula for 10 min (Period 2) after a 4-week washout period

干预措施: high flow nasal cannula and nasal cannula (Device)

结局指标

主要结局

R5

时间窗: immediately after 10 minutes of HFNC or NC

Changes of R5

R5%

时间窗: immediately after 10 minutes of HFNC or NC

Changes of R5%

R20%

时间窗: immediately after 10 minutes of HFNC or NC

Changes of R20%

R20

时间窗: immediately after 10 minutes of HFNC or NC

Changes of R20

X5-predicted

时间窗: immediately after 10 minutes of HFNC or NC

Changes of X5-predicted

Changes of R5-20

时间窗: immediately after 10 minutes of HFNC or NC

R5-20

X5-predicted%

时间窗: immediately after 10 minutes of HFNC or NC

Changes of X5-predicted%

Changes of Fres

时间窗: immediately after 10 minutes of HFNC or NC

Fres

Changes of Fres%

时间窗: immediately after 10 minutes of HFNC or NC

Fres%

Ax%

时间窗: immediately after 10 minutes of HFNC or NC

Changes of Ax%

Changes of Ax

时间窗: immediately after 10 minutes of HFNC or NC

Ax

次要结局

  • respiratory rate(immediately after 10 minutes of HFNC or NC)
  • both systolic and diastolic blood pressure(immediately after 10 minutes of HFNC or NC)
  • PEF(immediately after 10 minutes of HFNC or NC)
  • FEV1%(immediately after 10 minutes of HFNC or NC)
  • FVC(immediately after 10 minutes of HFNC or NC)
  • PEF%(immediately after 10 minutes of HFNC or NC)
  • FEV1/FVC%(immediately after 10 minutes of HFNC or NC)
  • Changes of MMEF%(immediately after 10 minutes of HFNC or NC)
  • Body temperature(immediately after 10 minutes of HFNC or NC)
  • Changes of FEV3(immediately after 10 minutes of HFNC or NC)
  • MMEF(immediately after 10 minutes of HFNC or NC)
  • TcPCO2(immediately after 10 minutes of HFNC or NC)
  • pulse rate(immediately after 10 minutes of HFNC or NC)
  • SpO2(immediately after 10 minutes of HFNC or NC)
  • FEV1(immediately after 10 minutes of HFNC or NC)
  • FVC%(immediately after 10 minutes of HFNC or NC)
  • FEV3%(immediately after 10 minutes of HFNC or NC)
  • FEV3/FVC%(immediately after 10 minutes of HFNC or NC)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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