Oxygen Treatment and Pulmonary Arterial Hypertension
2018年9月21日 更新者:Afroditi Boutou、George Papanicolaou Hospital
Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients
Pulmonary arterial hypertension (PAH) 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 PAH, 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, crossover 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 PAH, during steady state cardiopulmonary exercise testing (CPET)
研究概览
研究类型
介入性
注册 (预期的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Thessaloníki、希腊、57010
- 招聘中
- "G. Papanikolaou" General Hospital
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接触:
- Afroditi Boutou, MD, MSc, PhD
- 电话号码:00306946611433
- 邮箱:afboutou@yahoo.com
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Group I PAH patients
- Stable disease (no hospitalisation, disease deterioration or change in regular PAH medication during the last month)
- Presence of exercise-induced hypoxemia
Exclusion Criteria:
- Major contraindications for CPET conduction
- Not providing informed consent -
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:PAH patients
Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask
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40% FiO2 via Venturi mask
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假比较器:PAH patients (crossover)
Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask
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Medical air supplementation via Venturi mask
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Exercise duration
大体时间:through study completion, an average of a year
|
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion
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through study completion, an average of a year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Dyspnea
大体时间:through study completion, an average of a year
|
Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
|
through study completion, an average of a year
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cerebral oxygenated hemoglobin
大体时间:through study completion, an average of a year
|
minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
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through study completion, an average of a year
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Cardiac output
大体时间:through study completion an average of a year
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maximum cardiac output during steady state cardiopulmonary exercise testing
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through study completion an average of a year
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Fatigue
大体时间:through study completion, an average of a year
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Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing
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through study completion, an average of a year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Georgia Pitsiou, MD, Ass Prof、"G. Papanikolaou" General Hospital, Thessaloniki, Greece
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Dipla K, Boutou AK, Markopoulou A, Papadopoulos S, Kritikou S, Pitsiou G, Stanopoulos I, Kioumis I, Zafeiridis A. Differences in cerebral oxygenation during exercise in patients with idiopathic pulmonary fibrosis with and without exertional hypoxemia: does exercise intensity matter? Pulmonology. 2021 Jul 15:S2531-0437(21)00126-4. doi: 10.1016/j.pulmoe.2021.06.006. Online ahead of print.
- Boutou AK, Dipla K, Zafeiridis A, Markopoulou A, Papadopoulos S, Kritikou S, Panagiotidou E, Stanopoulos I, Pitsiou G. A randomized placebo-control trial of the acute effects of oxygen supplementation on exercise hemodynamics, autonomic modulation, and brain oxygenation in patients with pulmonary hypertension. Respir Physiol Neurobiol. 2021 Aug;290:103677. doi: 10.1016/j.resp.2021.103677. Epub 2021 May 3.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年6月5日
初级完成 (预期的)
2019年6月10日
研究完成 (预期的)
2019年6月30日
研究注册日期
首次提交
2018年9月20日
首先提交符合 QC 标准的
2018年9月21日
首次发布 (实际的)
2018年9月25日
研究记录更新
最后更新发布 (实际的)
2018年9月25日
上次提交的符合 QC 标准的更新
2018年9月21日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.