Continuous Measurement of Breathlessness

描述（由申请人提供）：本研究的目的是评估一种计算机辅助的连续测量运动中呼吸困难的方法。该方法代表了一种新的方法，以获得主观评级，从患者在自行车计力器或跑步机上锻炼。尽管每年有100多万患者使用“金标准”博格量表来测量呼吸困难，但它受到这样一个事实的限制：每次评估都是在由卫生专业人员提示或发出信号的离散时间点进行的，而不是在患者感觉到症状强度变化时进行的。此外，如果患者不能用语言表达反应（例如，在通过嘴呼吸时），则必须在量表上用手指指示等级。在运动过程中，这可能导致临床医生不确定患者所指的确切位置。获得患者主动评分的连续方法不受这些限制的阻碍，同时也提供了呼吸困难绝对阈值和峰值的直接测量。该软件获得这样的评级已被证明是可靠的，有效的，并易于使用。目前，该方法已成功应用于慢性阻塞性肺疾病患者。II期的目标是在更广泛的哮喘、间质性肺疾病、呼吸肌无力和肺血管疾病的成年患者以及一组哮喘儿童样本中评估新方法。还将进行试验，以调查连续方法的反应性，以跟踪支气管扩张剂治疗和呼吸负荷的影响。建议的商业应用。商业目标是用一种计算机管理的连续方法取代离散的体重计来测量运动中的呼吸困难。在第三阶段销售的产品将是一个计算机软件包，世界各地的医生、诊所和医院将购买该软件包。

DESCRIPTION (provided by applicant): The objective of this research is to evaluate a computer-assisted, continuous method for measuring breathlessness during exercise. The method represents a new approach to obtain subjective ratings from patients exercising on a cycle ergometer or treadmill. Whereas the "gold standard" Borg scale for measuring breathlessness is employed in over one million patients per year, it is limited by the fact that each estimate occurs at a discrete point in time cued or signaled by the health professional, rather than when the patient senses a change in symptom intensity. Moreover, if the patient cannot verbalize a response (e.g., while breathing through a mouthpiece), the rating must be indicated on the scale by finger pointing. During exercise this can lead to uncertainty on the part of the clinician as to exactly where the patient is pointing. The continuous method for obtaining patient-initiated ratings is unencumbered by these limitations, while also providing a direct measure of the absolute threshold and peak of breathlessness. The software to obtain such ratings has been shown to be reliable, valid, and easy to use. Thus far, the method has been successfully applied in patients with chronic obstructive pulmonary disease. The goal of Phase II is to evaluate the new methodology with a wider sample of adult patients afflicted with asthma, interstitial lung disease, respiratory muscle weakness, and pulmonary vascular disease, as well as with a group of children with asthma. Tests will also be conducted to investigate the responsiveness of the continuous method to track the effects of bronchodilator therapy and respiratory load. PROPOSED COMMERCIAL APPLICATION. The commercial goal is to replace the discrete scale with a computer-administered continuous method for measuring breathlessness during exercise. The product marketed in Phase III will be a computer software package that will be purchased by physicians, clinics and hospitals throughout the world.