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）：慢性阻塞性肺疾病（COPD）每年在美国造成超过50万例住院治疗和超过10万例死亡。COPD目前是第四大死因;预计到2020年将成为美国第三大死因，到2030年将成为全球第三大死因。长期氧疗（LTOT）是通过连接到氧气源（如氧气浓缩器或压缩气体或液体氧气瓶）的鼻插管给予患者的，是唯一已被证明可改善心肺疾病所致严重低氧血症患者生存率的治疗方法;当24/7开氧处方时，死亡率的改善最大。LTOT还与住院和住院时间的显着减少以及生活质量的改善有关。坚持LTOT对COPD患者（在发病率和死亡率方面）和社会（在医疗保健成本节约方面）都有很大的益处。 临床医生和研究人员目前通过计算经由以下方法之一确定的平均每日使用来评估在给定时期内对LTOT的依从性：（1）记录氧气浓缩器的小时计读数;（2）计数氧气瓶的使用;或（3）称量液态氧储存器。集中器的小时计阅读仅提供给定时间段内的设备“通电”时间。使用的气瓶数量，或气瓶液氧容器重量的变化，只显示消耗的氧气量。与仅仅打开氧气源相反，所有这些患者依从性的测量都不能辨别患者实际上是佩戴鼻插管还是吸入氧气。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。也没有一种可靠的手段来监测氧气坚持成本控制。 基于评估LTOT依从性的现有方法的研究表明，许多患者不遵循医生规定的治疗方案，导致治疗不足和报销费用浪费。为了让医生能够定期与患者就LTOT治疗和坚持对他们健康的重要性进行沟通，必须对患者的依从性进行准确和客观的测量。拟议的I期项目将建立一个用于长期氧疗患者的连续氧疗监测仪（COMPANY）功能原型，该原型可逐分钟客观地确定氧疗依从性的持续时间和模式。随着第一阶段可靠的监测仪的开发和演示，可以测量患者的依从性24/7，第二阶段的努力将集中在开发一个商业产品原型，也oers互联网连接的监测由医疗保健提供者和一个交互式的病人界面，提供信息，有意的，教育和激励反馈，以鼓励和改善依从性，并相应地，健康结果。 公共卫生关系：接受LTOT的患者社区人数约为80万，仅氧气治疗的费用就占耐用医疗设备医疗保险总支出的约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，以增加长期的临床选择性和成本控制，并进行研究以解决LTOT在间歇性低氧血症患者中的益处等争议。拟议的系统将提供一个可选的，实用的，和fordable的方法，可靠地评估LTOT坚持在临床实践和研究设置。