Palliative Oxygen for the Relief of Breathlessness

描述（由申请人提供）：呼吸困难的管理是生命限制性疾病患者护理的核心挑战。与其他症状不同，呼吸困难是在生命结束时出现的;它所造成的痛苦程度与疼痛和疲劳所造成的痛苦和残疾相当。尽管氧疗被广泛使用，但它在这种情况下的作用仍然存在争议。氧气明显有益于严重低氧血症（PaO 2小于或等于5 mmHg）的人。当PaO 2大于55 mmHg且不符合家庭氧气的其他资助标准时，通常会在同情的基础上为患有顽固性呼吸困难的人提供姑息性氧气。在这些情况下，目标是缓解呼吸困难的感觉和改善生活质量，但我们不知道这种治疗的有效性或负担。我们准备对姑息性氧气在缓解呼吸困难方面的作用进行最终研究，该研究由该领域的多学科国际领导人组成，他们已经证明了他们对该项目的承诺以及通过试点可行性研究和以前的合作努力共同努力的能力。本研究是一项在姑息治疗环境中比较氧气与医用空气的国际多中心随机双盲对照试验。具体目标是测试氧气与空气在缓解呼吸困难感和改善生活质量方面的有效性，确定干预措施的效果和负担的预测因素，并分析成本。符合条件的参与者在休息时或最小用力时存在顽固性呼吸困难，并且PaO 2> 55 mmHg;将从三大洲的七个研究中心招募240名参与者。氧气或医用空气将通过外观相同的浓缩器和鼻插管输送7天;受试者和研究者将对所提供的气体保持盲态。结果指标反映了具体目标，主要结果是0-10数值评定量表上的呼吸困难。招募和审判执行的可行性已进行试点。病例报告表已定稿。设计并试用了一个安全的网络数据管理系统。所有标准作业程序都已到位。这项研究是可行的，并准备启动。生命末期的呼吸困难对患者和护理人员来说都是痛苦的。这项研究的结果将大大提高我们对如何更好地照顾这一大群痛苦的人的认识。这一结果也将推动一个长期存在的关于姑息性氧气治疗顽固性呼吸困难的作用及其资金的国际辩论。

DESCRIPTION (provided by applicant): Management of breathlessness is a central challenge in the care of patients with life-limiting illness. Unlike other symptoms, breathlessness worsens at the end of life; the magnitude of distress it causes is on par with the distress and disability caused by pain and fatigue. The role of oxygen therapy in this setting remains controversial despite its widespread use. Oxygen clearly benefits people with severe hypoxemia (PaO2 less than or equal to 5mmHg). When PaO2 is greater than 55mmHg and other funding criteria for home oxygen are not met, palliative oxygen is commonly provided on a compassionate basis for people with intractable breathlessness. In these cases the goal is relief of the sensation of breathlessness and improvement in quality of life, yet we do not know how effective or burdensome such treatment is. We are poised to conduct the definitive study of the role of palliative oxygen for the relief of breathlessness conducted by a multi-disciplinary group of international leaders in the field who have proven their commitment to the project and ability to work together through pilot feasibility studies and previous collaborative efforts. This study is an international multi-center randomized double-blind controlled trial of oxygen versus medical air in the palliative care setting. The specific aims are to test the effectiveness of oxygen versus air in relieving the sensation of breathlessness and improving quality of life, to identify predictors of effect and burdens of the interventions, and to analyze costs. Eligible participants have intractable breathlessness at rest or with minimal exertion and PaO2>55mmHg; 240 participants will be recruited from seven sites on three continents. Oxygen or medical air will be delivered through identical appearing concentrators and nasal cannulae for seven days; participants and investigators will be blinded to the gas provided. Outcome measures reflect the specific aims and the primary outcome is breathlessness on a 0-10 numerical rating scale. Feasibility of recruitment and trial execution have been piloted. The case report forms has been finalized. A secure web-based data management system have been designed and piloted. All standard operating procedures are in place. This study is feasible and ready to be initiated. Breathlessness at the end of life is distressing to patients and caregivers. The results of this study will significantly advance our knowledge of how to better care for this large group of distressed individuals. The results will also advance a long-standing international debate about the role of palliative oxygen for intractable dyspnea and it's funding.