Continuous Measurement of Breathlessness

描述（由申请人提供）：本研究的目的是评价一种用于测量运动期间呼吸困难的计算机辅助连续方法。该方法代表了一种新的方法来获得主观评级的患者行使自行车测力计或跑步机。尽管用于测量呼吸困难的“金标准”博格量表每年被用于超过一百万的患者，但是它受到以下事实的限制：每个估计发生在由健康专业人员提示或发出信号的离散时间点，而不是当患者感觉到症状强度的变化时。此外，如果患者不能用语言表达响应（例如，当通过吹口呼吸时），必须用手指在刻度上指示等级。在锻炼期间，这可能导致临床医生不确定患者指的确切位置。用于获得患者发起的评级的连续方法不受这些限制的阻碍，同时还提供了对呼吸困难的绝对阈值和峰值的直接测量。获得这种评级的软件已被证明是可靠的，有效的，易于使用。到目前为止，该方法已成功应用于慢性阻塞性肺疾病患者。第二阶段的目标是用更广泛的患有哮喘、间质性肺病、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来评估新方法。还将进行试验以研究连续方法的响应性，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。其商业目标是用计算机管理的连续方法取代离散量表，用于测量运动期间的呼吸困难。在第三阶段上市的产品将是一个计算机软件包，将由世界各地的医生、诊所和医院购买。

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.