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）每年造成500,000多次住院和100,000多人死亡。 COPD目前是死亡​​的第四个主要原因。预计到2020年，它将成为美国的第三主要死亡原因，到2030年在全球范围内。长期氧疗法（LTOT），通过连接到氧气来源的鼻套管对患者进行施用，例如氧气浓缩剂或压缩机或液体氧气囊肿是唯一可以改善不足的氧气，以改善严重的氧化剂，以改善严重的氧化量。当氧气24/7处方时，死亡率的改善最大。 LTOT还与住院和住院时间的大幅减少以及改善的生活质量有关。遵守LTOT的好处对于COPD患者（就发病率和死亡率而言）和社会（就医疗保健成本节省而言）而言都是很大的。 临床医生和研究人员目前通过计算通过以下方法确定的平均每日使用来评估对LTOT的依从性：（1）记录氧气中心体的小时读数； （2）计数氧气缸的用法；或（3）称重液体氧气。集中器的小时表读数仅提供设备\在给定时间段内的时间。使用的圆柱体数量或气缸液体氧气的重量变化仅显示出所消耗的氧气的量。所有这些度量都无法识别出患者的依从性，如果实际上不识别出鼻孔或富含氧气的屈光度，则无法识别出相反的氧气，并且是对相反的屈服，并且是对相反的。当前的措施无法在每个24小时内提供有关氧气使用模式的信息，目前没有可靠的手段在临床实践中或评估LTOT依从性的研究环境中，也没有可靠的方法来监测基于成本遏制的氧气依从性。浪费了补偿金。提出的I期项目将对长期氧疗法（遵守）功能原型建立连续的氧气监测仪，该原型在客观地确定氧气治疗的持续时间和模式。随着可靠监测仪的I期的开发和演示，可以衡量患者依从性24/7，II期的工作将着重于开发商业产品原型，该原型还通过医疗保健提供者和互动的患者界面进行了互联网连接的监控，并提供了信息，有意，有意的，教育和动机的反馈，以鼓励和改善依从性和相应地，相应地改善健康和健康。 公共卫生相关性：接受LTOT数量约为800,000的患者社区，仅氧气疗法的成本代表了耐用的医疗设备的医疗保险总支出约为30％（13亿美元）。需要一种测量患者遵守LTOT的客观和准确的方法，以增强长期的临床选举和成本遏制，并为解决诸如LTOT在间歇性低氧患者中的益处等争议。拟议的系统将提供一种选择性，实用和可靠的方法，用于可靠地评估临床实践和研究环境中的LTOT依从性。