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临床试验/NCT03843723
NCT03843723已完成不适用

Exercise Pulse Oximetry and Pre-flight Evaluation of Adult Cystic Fibrosis (CF) Patients

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
1
主要终点
Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?

研究概览

简要总结

Due to the hypobaric hypoxia during air travel, some patients with Cystic Fibrosis (CF) need supplemental oxygen during air travel.

The study aims to evaluate if adding exercise desaturation to the pre-flight evaluation will help predict requirements for in-flight supplemental oxygen.

详细描述

According to the British Thoracic Society (BTS) recommendations regarding pre-flight evaluation in patients with pulmonary disease, pre-flight arterial oxygen saturation or lung function tests do not discriminate sufficiently between those who need supplemental oxygen during flights, and those who can do without.Therefore, more extensively use of Hypoxia Altitude Simulation test (HAST) has been advocated. However, this test is not widely available. Previous studies have shown that exercise testing is useful for the prediction of in-flight hypoxemia. The investigators have previously developed a pre-flight algorithm for patients with chronic obstructive pulmonary disease (COPD), based on oxygen saturation measured by pulse oximetry at rest and during exercise (six minute walking test (6MWT)). It remains unknown as to whether these results are applicable to the CF population.

The current study aims to validate the pre-flight algorithm for patients with CF. Since a maximum cardiopulmonary exercise test (CPET) is recommended in the routine CF-control, the investigators also aim to evaluate whether the use of CPET predicts in-flight hypoxemia with greater accuracy than 6MWT, and whether CPET may replace HAST.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Adult CF patients (age from 18 years)
  • Signed informed consent

排除标准

  • Ongoing exacerbation
  • Unable to fulfill a CPET or 6MWT
  • Long-term oxygen treatment (LTOT)
  • Severe heart disease
  • Language problems that interfere with data collection

结局指标

主要结局

Does oxygen saturation during exercise predict in-flight hypoxemia in adult patients with CF?

时间窗: 1 day

Oxygen saturation is measured by pulse oximetry (SpO2) during exercise and HAST

次要结局

未报告次要终点

研究者

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

Aina Akerø

Principal Investigator, MD PhD

Oslo University Hospital

研究点 (1)

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