Continuous Oxygen Monitor for Patients on Long-Term Oxygen Therapy (COMPLY)

适用于长期氧疗患者的连续氧气监测仪 (COMPLY)

• 批准号: 8123683
• 负责人: B EUGENE PARKER
• 金额: $ 19.84万
• 依托单位: BARRON ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-15 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8123683
• 关键词: Address; Adherence; Anterior nares; Biomedical Engineering; Breathing; Cannulas; Carbon Dioxide; Cause of Death; Cessation of life; Chronic Obstructive Airway Disease; Clinical; Clinical Management; Clinical Research; Comb animal structure; Communities; Cost Control; Cost Savings; Critical Care; Data; Development; Devices; Doctor of Philosophy; Durable Medical Equipment; Electronics; Equipment; Expenditure; Failure; Feedback; Frequencies; Gases; Goals; Health; Health Care Costs; Health Personnel; Home environment; Hospitalization; Hour; Human; Hypoxemia; Internet; Laboratories; Length; Length of Stay; Link; Liquid substance; Lung; Measures; Medical; Medical center; Medicare; Medicine; Methods; Monitor; Morbidity - disease rate; Mouth Breathing; Nose; Oral; Oral cavity; Outcome; Oxygen; Oxygen Therapy Care; Participant; Patient Monitoring; Patients; Pattern; Pennsylvania; Performance; Phase; Philadelphia; Physicians; Pulmonary Heart Disease; Quality of life; REM Sleep; Reading; Records; Research; Research Personnel; Running; Sampling; Signal Transduction; Sleep; Small Business Innovation Research Grant; Societies; Solutions; Source; System; Testing; Time; Transducers; Treatment Protocols; Tube; United States; United States Department of Veterans Affairs; Universities; Visual; Wakefulness; Weight; Work; airway obstruction; awake; base; clinical practice; compliance behavior; cost; design; foot; improved; innovation; meetings; member; meter; mortality; non rapid eye movement; pressure; professor; programs; prospective; prototype; pulmonary function; research study; response; sensor; therapy adherence; transmission process; validation studies; wasting

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease (COPD) is responsible for more than 500,000 hospitalizations and over 100,000 deaths in the United States annually. COPD is currently the fourth leading cause of death; it is projected to become the third leading cause of death in the U.S. by 2020 and worldwide by 2030. Long-term oxygen therapy (LTOT), which is administered to patients via a nasal cannula attached to an oxygen source, such as an oxygen concentrator or compressed-gas or liquid oxygen cylinder is the only treatment that has been shown to improve survival in severe hypoxemia due to cardiopulmonary diseases; the improvement in mortality is greatest when oxygen is prescribed 24/7. LTOT is also associated with significant reductions in hospitalizations and lengths of stay, and improved quality of life. The benefits of adherence to LTOT are substantial both to COPD patients (in terms of morbidity and mortality) and to society (in terms of healthcare cost savings). Clinicians and researchers currently assess adherence to LTOT over a given period by calculating the average daily use as determined via one of the following methods: (1) recording the hour-meter readings of oxygen con- centrators; (2) counting usage of oxygen cylinders; or (3) weighing liquid oxygen reservoirs. The concentrator's hour-meter reading provides only equipment \power-on" time over a given period. The number of cylinders used, or the change in weight of cylinder liquid oxygen reservoirs, reveals only the amount of oxygen expended. All of these measures of patient adherence fail to discern if the patient is actually wearing the nasal cannula or inhaling oxygen, as opposed to merely having the oxygen source turned on. Furthermore, current measures fail to provide information regarding the pattern of oxygen use within each 24-hour interval. There is currently no reliable means available in clinical practice or in research settings for assessing LTOT adherence. Nor is there a reliable means to monitor oxygen adherence for cost containment. Studies based on available methods for assessing adherence to LTOT indicate that many patients do not follow their physician's prescribed treatment regimen, resulting in inadequate therapy and wasted reimbursement dollars. For physicians to be able to communicate with their patients on a regular basis regarding their LTOT treatment and the importance of adherence to their health, it is essential to have accurate and objective measures of patients' adherence. The proposed Phase I project will establish a Continuous Oxygen Monitor for Patients on Long-term oxygen therapy (COMPLY) functional prototype that objectively determines the duration and pattern of adherence with oxygen therapy on a minute-by-minute basis. With the development and demonstration in Phase I of a reliable monitor that can measure patient adherence 24/7, the Phase II effort will focus on developing a commercial product prototype that also oers Internet-linked monitoring by healthcare providers and an interactive patient interface that provides informational, intentional, educational, and motivational feedback to encourage and improve adherence and, correspondingly, health outcomes. PUBLIC HEALTH RELEVANCE: The patient community receiving LTOT numbers approximately 800,000, and the cost of their oxygen therapy alone represents approximately 30% ($1.3 billion) of total Medicare expenditures for durable medical equipment. An objective and accurate method of measuring patient adherence to LTOT is required to augment clinical electiveness and cost containment for the long term, and for research studies to address such controversies as the benefits of LTOT in patients with intermittent hypoxemia. The proposed system will provide an elective, practical, and fordable method for reliably assessing LTOT adherence in clinical practice and research settings.

描述（由申请人提供）：美国每年有超过 500,000 人因慢性阻塞性肺疾病 (COPD) 住院治疗，并导致 100,000 多人死亡。慢性阻塞性肺病（COPD）目前是第四大死因；预计到 2020 年，它将成为美国第三大死亡原因，到 2030 年，它将成为全球第三大死亡原因。长期氧疗 (LTOT) 通过连接氧源（例如制氧机、压缩气体或液氧钢瓶）的鼻插管对患者进行治疗，是唯一已被证明可以改善心肺疾病导致的严重低氧血症患者生存的治疗方法；当全天候（24/7）吸氧时，死亡率的改善效果最大。 LTOT 还与住院治疗和住院时间的显着减少以及生活质量的提高有关。坚持 LTOT 对 COPD 患者（在发病率和死亡率方面）和社会（在节省医疗费用方面）都有很大的好处。 临床医生和研究人员目前通过计算平均每日使用量（通过以下方法之一确定）来评估给定时间内 LTOT 的依从性：（1）记录氧气浓缩器的小时计读数； （二）统计氧气瓶的使用情况；或(3)称量液氧储罐。集中器的计时表读数仅提供给定时间内设备的“通电”时间。使用的气瓶数量或气瓶液氧储罐的重量变化仅显示消耗的氧气量。所有这些患者依从性的测量都无法辨别患者是否确实佩戴鼻插管或吸入氧气，而不仅仅是打开氧气源。此外， 目前的措施无法提供有关每 24 小时间隔内氧气使用模式的信息。目前在临床实践或研究环境中没有可靠的方法可用于评估 LTOT 依从性。也没有可靠的方法来监测氧气依从性以控制成本。 基于评估 LTOT 依从性的现有方法的研究表明，许多患者没有遵循医生规定的治疗方案，导致治疗不足和 浪费了赔偿金。为了使医生能够定期与患者沟通 LTOT 治疗以及坚持健康的重要性，必须对患者的依从性进行准确、客观的测量。拟议的第一阶段项目将为长期氧疗患者建立一个连续氧监测仪（COMPLY）功能原型，客观地确定长期氧疗患者坚持氧疗的持续时间和模式。 以分钟为基础。随着第一阶段开发和演示可以 24/7 测量患者依从性的可靠监测仪，第二阶段工作将重点开发商业产品原型，该原型还提供医疗保健提供者的互联网连接监测和交互式患者界面，该界面提供信息、有意、教育和激励反馈，以鼓励和改善依从性，并相应地改善健康结果。 公共健康相关性：接受 LTOT 的患者群体约有 800,000 人，仅氧疗费用就约占 Medicare 耐用医疗设备总支出的 30%（13 亿美元）。需要一种客观、准确的方法来衡量患者对 LTOT 的依从性，以提高长期的临床选择性和成本控制，并进行研究以解决诸如 LTOT 对间歇性低氧血症患者的益处等争议。所提出的系统将为临床实践和研究环境中可靠评估 LTOT 依从性提供选择性、实用且可负担的方法。