Investigating the Accuracy of the Digihaler, a New Electronic Multidose Dry-Powder Inhaler, in Measuring Inhalation Parameters.

IF 2 4区 医学 Q3 RESPIRATORY SYSTEM
Henry Chrystyn, Dinesh Saralaya, Anil Shenoy, Sophie Toor, Kari Kastango, Enric Calderon, Thomas Li, Guilherme Safioti
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引用次数: 11

Abstract

Background: The Digihaler® is a Food and Drug Administration-approved, digital multidose dry powder inhaler with an integrated electronic module that provides patients and health care professionals with feedback on inhalation parameters, including usage, adherence, and technique. This study compared inhalation parameters measured using the Digihaler with readings made simultaneously using an inhalation profile recorder (IPR). Methods: This single-visit, open-label study enrolled children (4-17 years) and adults (18-55 years) with asthma, and adults (≥55 years) with chronic obstructive pulmonary disease (COPD). Participants made three separate inhalations using an empty Digihaler device, each measured simultaneously by the Digihaler and IPR. Inhalation profiles were downloaded from the devices at the end of the study. Inhalation parameters measured included peak inspiratory flow (PIF) and inhaled volume (inhV). The profile with the highest PIF and corresponding IPR profile were analyzed. Results: Overall, 150 participants were enrolled; inhalation data were available for 148 (50 children and 49 adults with asthma, and 49 with COPD). Mean (standard deviation [SD]) age was 39.1 (24.5) years; 51% of participants were male. Overall mean (SD) PIFs as measured by the Digihaler and IPR were 70.62 (17.73) L/min and 72.55 (19.42) L/min, respectively, with a mean percentage difference of -1.75% (95% confidence interval [CI]: -3.64 to 0.15). Mean percentage differences between the Digihaler and IPR measurements of PIF ranged from -2.97% among adults with COPD to 0.16% among children with asthma. Overall mean (SD) inhV for the Digihaler and IPR were 1.57 (0.69) L and 1.67 (0.73) L, respectively, with a mean percentage difference of -6.11 (95% CI: -8.08 to -4.13). There was a strong correlation between PIF and inhV measurements taken by the Digihaler and those taken by the IPR (Spearman's correlation coefficient = 0.96). Conclusions: Our findings confirm the ability of the Digihaler to provide accurate measurement of inhalation parameters when used by patients.

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新型电子多剂量干粉吸入器Digihaler测量吸入参数的准确性研究。
Digihaler®是美国食品和药物管理局批准的数字多剂量干粉吸入器,具有集成的电子模块,可为患者和医疗保健专业人员提供有关吸入参数的反馈,包括使用,依从性和技术。本研究比较了使用Digihaler测量的吸入参数与同时使用吸入剖面记录仪(IPR)的读数。方法:这项单次访问、开放标签的研究纳入了患有哮喘的儿童(4-17岁)和成人(18-55岁),以及患有慢性阻塞性肺疾病(COPD)的成人(≥55岁)。参与者使用空的Digihaler设备进行三次单独的吸入,每次吸入都由Digihaler和IPR同时测量。在研究结束时,从设备上下载吸入档案。测量的吸入参数包括吸入峰流量(PIF)和吸入量(inhV)。分析了PIF最高的剖面和相应的IPR剖面。结果:共纳入150名受试者;148人(50名儿童和49名成人哮喘患者,49名COPD患者)的吸入数据可用。平均(标准差[SD])年龄为39.1(24.5)岁;51%的参与者是男性。Digihaler和IPR测量的总体平均(SD) pif分别为70.62 (17.73)L/min和72.55 (19.42)L/min,平均百分比差为-1.75%(95%置信区间[CI]: -3.64至0.15)。Digihaler和IPR测量PIF的平均百分比差异在成人COPD患者中为-2.97%,在儿童哮喘患者中为0.16%。Digihaler和IPR的总体平均(SD) inhV分别为1.57 (0.69)L和1.67 (0.73)L,平均百分比差为-6.11 (95% CI: -8.08至-4.13)。由Digihaler和IPR测量的PIF和inhV之间有很强的相关性(Spearman相关系数= 0.96)。结论:我们的研究结果证实了Digihaler在患者使用时能够提供准确的吸入参数测量。
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来源期刊
CiteScore
6.70
自引率
2.90%
发文量
34
审稿时长
>12 weeks
期刊介绍: Journal of Aerosol Medicine and Pulmonary Drug Delivery is the only peer-reviewed journal delivering innovative, authoritative coverage of the health effects of inhaled aerosols and delivery of drugs through the pulmonary system. The Journal is a forum for leading experts, addressing novel topics such as aerosolized chemotherapy, aerosolized vaccines, methods to determine toxicities, and delivery of aerosolized drugs in the intubated patient. Journal of Aerosol Medicine and Pulmonary Drug Delivery coverage includes: Pulmonary drug delivery Airway reactivity and asthma treatment Inhalation of particles and gases in the respiratory tract Toxic effects of inhaled agents Aerosols as tools for studying basic physiologic phenomena.
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