Frima Eirini-Sofia, Theodorakopoulos Ilias, Gidaris Dimos, Karantaglis Nikolaos, Chatziparasidis Grigorios, Plotas Panagiotis, Anthracopoulos Michael, Fouzas Sotirios
Pediatric Respiratory Unit, University Hospital of Patras, Patras, Greece.
Pediatric Respiratory Research Group, University of Patras, Patras, Greece.
JMIR Res Protoc. 2020 Aug 7;9(8):e20350. doi: 10.2196/20350.
Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 second (FEV1) has been used in research to predict exacerbations in adults with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in healthy children and adolescents and those with asthma.
The objective of this study is the assessment of PEF and FEV1 variability in (1) healthy children and adolescents, to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and (2) children and adolescents with asthma, to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation.
The study will include 100 healthy children and adolescents aged 6-18 years (assessment of normal PEF and FEV1 variability) and 100 children and adolescents of the same age with diagnosed asthma (assessment of PEF and FEV1 variability in subjects with asthma). PEF and FEV1 measurements will be performed using an ultraportable spirometer (Spirobank Smart; MIR Medical International Research) capable of smartphone connection. Measurements will be performed twice a day between 7 AM and 9 AM and between 7 PM and 9 PM and will be dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation and sample entropy analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify any deviations among individuals with asthma. The anticipated duration of the study is 24 months.
The study is funded by the "C. Caratheodory" Programme of the University of Patras, Greece (PN 47014/24.9.2018). It was approved by the Ethics Committee (decision 218/19-03-2019) and the Scientific Board (decision 329/02-04-2019) of the University Hospital of Patras, Greece. Patient recruitment started in January 2020, and as of June 2020, 100 healthy children have been enrolled (74 of them have completed the measurements). The anticipated duration of the study is 24 months. The first part of the study (assessment of lung function variability in healthy children and adolescents) will be completed in August 2020, and the results will be available for publication by October 2020.
Healthy children and adolescents may present normal short- and long-term fluctuations in lung function; the pattern of this variability may be influenced by age, sex, and environmental conditions. Significant lung function variability may also be present in children and adolescents with asthma, but the patterns may differ from those observed in healthy children and adolescents. Such data would improve our understanding regarding the chronobiology of asthma and permit the development of integrated tools for assessing the level of control and risk of future exacerbations.
ClinicalTrials.gov NCT04163146; https://clinicaltrials.gov/ct2/show/NCT04163146.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20350.
呼气峰值流速（PEF）和第1秒用力呼气容积（FEV1）的变异性分析已用于研究预测成年哮喘患者的病情加重情况。然而，关于健康儿童和青少年以及哮喘患儿的PEF和FEV1变异性的数据却很匮乏。
本研究的目的是评估（1）健康儿童和青少年的PEF和FEV1变异性，以确定PEF和FEV1的正常每日波动情况以及可能影响其的参数；（2）哮喘患儿和青少年的PEF和FEV1变异性，以探索与健康受试者的差异，并揭示病情加重前的任何特定变异性变化。
该研究将纳入100名6至18岁的健康儿童和青少年（评估正常PEF和FEV1变异性）以及100名同龄且已确诊哮喘的儿童和青少年（评估哮喘患者的PEF和FEV1变异性）。将使用能够连接智能手机的超便携式肺活量计（Spirobank Smart；MIR Medical International Research）进行PEF和FEV1测量。测量将在上午7点至9点以及晚上7点至9点之间每天进行两次，并通过电子邮件发送至中央数据库，为期3个月。将通过去趋势波动和样本熵分析评估PEF和FEV1变异性，旨在确定正常模式（健康对照），并检测和量化哮喘患者个体之间的任何偏差。该研究预期持续时间为24个月。
该研究由希腊帕特雷大学的“C.卡拉西奥多里”计划资助（项目编号47014/24.9.2018）。它获得了希腊帕特雷大学医院伦理委员会（2019年3月218号决定）和科学委员会（2019年4月2日第329号决定）的批准。患者招募于2020年1月开始，截至20年6月，已招募100名健康儿童（其中74名已完成测量）。该研究预期持续时间为24个月。研究的第一部分（评估健康儿童和青少年的肺功能变异性）将于2020年8月完成，结果将于2020年10月可供发表。
健康儿童和青少年的肺功能可能会出现正常的短期和长期波动；这种变异性模式可能受年龄、性别和环境条件影响。哮喘患儿和青少年也可能存在显著的肺功能变异性，但其模式可能与健康儿童和青少年中观察到的不同。此类数据将增进我们对哮喘时间生物学的理解，并有助于开发用于评估控制水平和未来病情加重风险的综合工具。
ClinicalTrials.gov NCT04163146；https://clinicaltrials.gov/ct2/show/NCT04163146。
国际注册报告识别码（IRRID）：DERR1-10.2196/20350。
