跳至主要内容
临床试验/NCT05583396
NCT05583396招募中不适用

Pulmonary Diffusing Capacity to Nitric Oxide and Carbon Monoxide During Exercise in Patients With Chronic Obstructive Pulmonary Disease: a Test-retest Reliability Study

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年11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
招募中
入组人数
15
试验地点
2
主要终点
CV for VA at rest

研究概览

简要总结

The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) during exercise may be a useful physiological measure of alveolar-capillary reserve in patients with Chronic obstructive pulmonary disease (COPD). The present study investigated the test-retest reliability of DLCO/NO-based metrics.

详细描述

The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. These changes are thought to involve acute changes in pulmonary perfusion and are notably relevant for patients with chronic obstructive pulmonary disease (COPD), in which they may be related to exertional dyspnoea. The aim of the present study is to investigate the effects of acute exercise on pulmonary diffusing capacity, and to determine the day-to-day repeatability of such assessments.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic obstructive pulmonary disease (GOLD II + III)

排除标准

  • Known heart disease
  • Pregnancy
  • Disease within two weeks prior to inclusion

研究组 & 干预措施

Acute exercise

Other

Pulmonary diffusing capacity using the DLCO/NO technique is assessed at rest and during exercise (60% of maximal workload on a bicycle ergometer)

干预措施: Acute exercise (Diagnostic Test)

结局指标

主要结局

CV for VA at rest

时间窗: Measured at day 1 and day 2

CV with 95% CI for VA at rest

CV for VA during exercise

时间窗: Measured at day 1 and day 2

CV with 95% CI for VA during exercise

ICC for DLCOc at rest

时间窗: Measured at day 1 and day 2

ICC for DLCOc with 95% CI at rest

Intraclass correlation coefficient (ICC) for DLNO during exercise

时间窗: Measured at day 1 and day 2

ICC for DLNO with 95% CI during exercise

Rest-to-exercise change in DLNO

时间窗: Measured at day 1 and day 2

The physiological change from rest to exercise in DLNO obtained using the combined DLCO/NO technique with a 5-sec breathhold.

Rest-to-exercise change in DM

时间窗: Measured at day 1 and day 2

The physiological change from rest to exercise in DM obtained using the combined DLCO/NO technique with a 5-sec breathhold.

CV for DM at rest

时间窗: Measured at day 1 and day 2

CV with 95% CI for DM at rest

SRD for Diffusion capacity for carbon monoxide (DLCOc) at rest

时间窗: Measured at day 1 and day 2

SRD with 95% CI for DLCOc at rest

Rest-to-exercise change in VC

时间窗: Measured at day 1 and day 2

The physiological change from rest to exercise in VC obtained using the combined DLCO/NO technique with a 5-sec breathhold.

Rest-to-exercise change in VA

时间窗: Measured at day 1 and day 2

The physiological change from rest to exercise in VA obtained using the combined DLCO/NO technique with a 5-sec breathhold.

SRD for DLNO during exercise

时间窗: Measured at day 1 and day 2

SRD with 95% CI for DLNO during exercise

SRD for DLCOc during exercise

时间窗: Measured at day 1 and day 2

SRD with 95% CI for DLCOc during exercise

SRD for Pulmonary blood volume (Vc) at rest

时间窗: Measured at day 1 and day 2

SRD with 95% CI for Vc at rest

SRD for VA during exercise

时间窗: Measured at day 1 and day 2

SRD with 95 % CI for VA during exercise

CV for DLNO during exercise

时间窗: Measured at day 1 and day 2

CV with a 95% CI during exercise

CV for DLCOc during exercise

时间窗: Measured at day 1 and day 2

CV with 95% CI for DLCOc during exercise

CV for DM during exercise

时间窗: Measured at day 1 and day 2

CV with 95% CI for DM during exercise

CV for Vc at rest

时间窗: Measured at day 1 and day 2

CV with 95% CI for DM at rest

CV for Vc during exercise

时间窗: Measured at day 1 and day 2

CV with 95% CI for DM during exercise

Intraclass correlation coefficient (ICC) for DLNO at rest

时间窗: Measured at day 1 and day 2

ICC for DLNO with 95% CI at rest

Rest-to-exercise change in DLCOc

时间窗: Measured at day 1 and day 2

The physiological change from rest to exercise in DLCOc obtained using the combined DLCO/NO technique with a 5-sec breathhold.

Smallest real difference (SRD) for Diffusion capacity for DLNO at rest

时间窗: Measured at day 1 and day 2

SRD with 95 % confidence intervals (95% CI) for DLNO at rest

SRD for membrane diffusing capacity (DM) at rest

时间窗: Measured at day 1 and day 2

SRD with 95% CI for DM at rest

SRD for DM during exercise

时间窗: Measured at day 1 and day 2

SRD with 95% CI for DM during exercise

SRD for Vc during exercise

时间窗: Measured at day 1 and day 2

SRD with 95% CI for Vc during exercise

SRD for alveolar volume (VA) at rest

时间窗: Measured at day 1 and day 2

SRD with 95 % CI for VA at rest

Coefficient of Variance (CV) for DLNO at rest

时间窗: Measured at day 1 and day 2

CV with a 95% CI at rest

CV for DLCOc at rest

时间窗: Measured at day 1 and day 2

CV with 95% CI for DLCOc at rest

ICC for VC at rest

时间窗: Measured at day 1 and day 2

ICC for VC with 95% CI at rest

ICC for DLCOc during exercise

时间窗: Measured at day 1 and day 2

ICC for DLCOc with 95% CI during exercise

ICC for DM at rest

时间窗: Measured at day 1 and day 2

ICC for DM with 95% CI at rest

ICC for VC during exercise

时间窗: Measured at day 1 and day 2

ICC for VC with 95% CI during exercise

ICC for VA during exercise

时间窗: Measured at day 1 and day 2

ICC for VA with 95% CI during exercise

ICC for DM during exercise

时间窗: Measured at day 1 and day 2

ICC for DM with 95% CI during exercise

ICC for VA at rest

时间窗: Measured at day 1 and day 2

ICC for VA with 95% CI at rest

次要结局

  • Breath hold time during exercise(Measured at day 1 and day 2)
  • Alveolar volume (VA) during exercise(Measured at day 1 and day 2)
  • Diffusion capacity for carbon monoxide (DLCOc) during exercise(Measured at day 1 and day 2)
  • Membrane diffusing capacity (DM) during exercise(Measured at day 1 and day 2)
  • Bland Altman Plot - DLNO(Measured at day 1 and day 2)
  • Bland Altman Plot - DM(Measured at day 1 and day 2)
  • Bland Altman Plot - VA(Measured at day 1 and day 2)
  • Diffusion capacity for nitric oxide (DLNO) at rest(Measured at day 1 and day 2)
  • Diffusion capacity for carbon monoxide (DLCOc) at rest(Measured at day 1 and day 2)
  • Membrane diffusing capacity (DM) at rest(Measured at day 1 and day 2)
  • Pulmonary blood volume (Vc) at rest(Measured at day 1 and day 2)
  • Pulmonary blood volume (Vc) during exercise(Measured at day 1 and day 2)
  • Breath hold time at rest(Measured at day 1 and day 2)
  • Diffusion capacity for nitric oxide (DLNO) during exercise(Measured at day 1 and day 2)
  • Alveolar volume (VA) at rest(Measured at day 1 and day 2)
  • Bland Altman Plot - DLCOc(Measured at day 1 and day 2)
  • Bland Altman Plot - VC(Measured at day 1 and day 2)

研究者

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

Ronan Berg

MD, DMSc, Associate Professor, Principal investigator

Rigshospitalet, Denmark

研究点 (2)

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