Palliative Oxygen for the Relief of Breathlessness

姑息性氧气缓解呼吸困难

• 批准号: 7286323
• 负责人: AMY P. ABERNETHY
• 金额: $ 52.71万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-15 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7286323
• 关键词: Adverse effects; Air; Australia; Blinded; Canada; Cancer Patient; Cannulas; Caregivers; Caring; Case Report Form; Characteristics; Clinical; Cost Analysis; Developed Countries; Developing Countries; Distress; Double-Blind Method; Dyspnea; Dyspnea Management; Effectiveness; Esthesia; Exertion; Fatigue; Feasibility Studies; Funding; Gases; Goals; Government Agencies; Guidelines; Healthcare; Home environment; Hospice Care; Hypoxemia; Individual; International; Intervention; Knowledge; Life; Longitudinal Studies; Malignant Neoplasms; Medical; Nose; Online Systems; Outcome; Outcome Measure; Oxygen; Oxygen Therapy Care; Pain; Palliative Care; Participant; Patient Care; Patients; Pattern; Population; Procedures; Qualifying; Quality of life; Randomized; Randomized Controlled Clinical Trials; Rate; Recruitment Activity; Research Personnel; Rest; Risk; Role; Secure; Services; Severity of illness; Signal Transduction; Site; Standards of Weights and Measures; Symptoms; System; Terminally Ill; Testing; United Kingdom; United States; Work; base; compare effectiveness; cost; data management; day; design; disability; eligible participant; end of life; hospice environment; improved; programs

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.

描述（由申请人提供）：呼吸困难的管理是对生命受限疾病患者护理的核心挑战。与其他症状不同，呼吸困难在生命结束时恶化；它造成的痛苦程度与疼痛和疲劳造成的痛苦和残疾相当。氧疗在这种情况下的作用尽管广泛使用，但仍存在争议。氧气显然有利于严重低氧血症（PaO2小于或等于5mmHg）的患者。当PaO2大于55mmHg且不符合家庭供氧的其他资助标准时，通常在同情的基础上为难治性呼吸困难患者提供姑息性供氧。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效果或负担。我们准备对缓和氧气在缓解呼吸困难方面的作用进行明确研究，由该领域的多学科国际领导人组成的小组进行研究，他们已经证明了他们对项目的承诺，并通过试点可行性研究和以前的合作努力共同努力。本研究是一项国际多中心随机双盲对照试验，比较缓和医疗环境中的氧气与医用空气。具体目的是测试氧气与空气在缓解呼吸困难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或最小运动时存在难治性呼吸困难，PaO2 bb0 55mmHg；将从三大洲的七个地点招募240名参与者。氧气或医用空气将通过相同的表面浓缩器和鼻插管输送7天；参与者和调查人员将不会看到所提供的气体。结果测量反映了具体的目标和主要结果是呼吸困难在0-10数值评级尺度上。已对征聘和审判执行的可行性进行了试点。病例报告表已经定稿。一个安全的基于网络的数据管理系统已经设计和试验。所有标准操作程序都已到位。这项研究是可行的，准备开始。生命末期的呼吸困难对病人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个体的认识。这一结果也将推动长期以来国际上关于姑息性氧气治疗难治性呼吸困难的作用及其资金的争论。