Acute Effects of Oxygen Supplementation Among IPF Patients
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状态招聘中
赞助商
George Papanicolaou Hospital
临床试验: NCT03688334
BioSeek: nct03688334
关键词
抽象
Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial.
Based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET).
日期
| 最后验证: | 08/31/2018 |
| 首次提交: | 09/19/2018 |
| 提交的预估入学人数: | 09/26/2018 |
| 首次发布: | 09/27/2018 |
| 上次提交的更新: | 09/26/2018 |
| 最近更新发布: | 09/27/2018 |
| 实际学习开始日期: | 05/31/2018 |
| 预计主要完成日期: | 05/31/2019 |
| 预计完成日期: | 05/31/2019 |
状况或疾病
Idiopathic Pulmonary Fibrosis
干预/治疗
Drug: IPF patients
Drug: IPF patients (crossover)
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: IPF patients Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing | Drug: IPF patients Oxygen supplementation (40%) via Venturi mask |
| Sham Comparator: IPF patients (crossover) Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing | Drug: IPF patients (crossover) Medical air supplementation via Venturi mask |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: Stable IPF patients with no hospitalization, exacerbation or change in regular IPF medication during the last month, who do not present with resting hypoxemia, but manifest exercise induced hypoxemia Exclusion Criteria: 1. Major contraindications for CPET conduction 2. Not provision of informed consent - |
结果
主要结果指标
1. Exercise duration [through study completion, an average of a year]
Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion
次要成果指标
1. Dyspnea [through study completion, an average of a year]
maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing
2. Fatigue [through study completion, an average of a year]
maximum fatigue assessed by Borg's Rating of Perceived Exertion Scale (range from 6: no exertion to 20: maximal exertion), during steady state cardiopulmonary exercise testing
其他成果措施
1. Cerebral oxygenated hemoglobin [through study completion, an average of a year]
The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
2. Cardiac output [through study completion, an average of a year]
The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing
