Department of Paediatric Pulmonology and Neonatology, Medizinische Hochschule Hannover, Hannover, Germany.
Pediatr Pulmonol. 2009 Dec;44(12):1180-5. doi: 10.1002/ppul.21093.
There is increasing interest in using the Multiple Breath Washout technique and the lung clearance index (LCI) for detecting early pulmonary changes, for example, in cystic fibrosis lung disease. However, there are still limited data regarding equipment specific reference ranges, repeatability and reproducibility. The aim of this prospective study was to assess within-test repeatability, short term reproducibility and long term reproducibility, and to establish normal values for the LCI in healthy children and adolescents using the sidestream ultrasonic flow sensor (EasyOne Pro, MBW Module, ndd Medical Technologies, Switzerland). Fourty-four volunteers (5.3-20.3 years) were recruited for the 1st test. Twenty-two out of 44 were measured on a 2nd test occasion after an interval of 1 hr (2nd test). Thirty-four out of 44 agreed to come back for a follow up test 6-15 months later (3rd test). Mean LCI (SD) was 6.2 (0.4), 6.3 (0.4), and 6.0 (0.4) at the 1st, 2nd, and 3rd test. The upper limit of normal was 7.0 for all subjects. Within-test repeatability was 5.1%. Short-term reproducibility (1st test vs. 2nd test) was 4.2% with a mean difference of -0.13 (95% CI -0.350; 0.087). Long-term reproducibility (1st test vs. 3rd test) was 5.1%, with a mean difference of 0.017 (95% CI -0.016; 0.348). With this low variability of the LCI for both, within and between tests, our study demonstrates reliability and robustness of equipment, protocol and analysis and the reliability of the MBW technique in general. The present data will help to interpret the effect of therapeutic interventions and interpretation of longitudinal data in patients with pulmonary diseases.
人们越来越感兴趣地使用多呼吸冲洗技术和肺清除指数 (LCI) 来检测早期肺部变化,例如在囊性纤维化肺病中。然而,关于特定设备的参考范围、重复性和再现性的数据仍然有限。本前瞻性研究的目的是评估测试内重复性、短期再现性和长期再现性,并使用旁流超声流量传感器(EasyOne Pro,MBW 模块,ndd Medical Technologies,瑞士)为健康儿童和青少年建立 LCI 的正常值。44 名志愿者(5.3-20.3 岁)被招募参加第 1 次测试。其中 22 名在 1 小时间隔后进行第 2 次测试(第 2 次测试)。44 名中有 34 名同意在 6-15 个月后回来进行随访测试(第 3 次测试)。第 1、2 和第 3 次测试时 LCI(SD)的平均值分别为 6.2(0.4)、6.3(0.4)和 6.0(0.4)。所有受试者的正常上限均为 7.0。测试内重复性为 5.1%。短期再现性(第 1 次测试与第 2 次测试)为 4.2%,平均差异为-0.13(95%CI-0.350;0.087)。长期再现性(第 1 次测试与第 3 次测试)为 5.1%,平均差异为 0.017(95%CI-0.016;0.348)。由于 LCI 的这种低变异性,无论是在测试内还是测试间,本研究都证明了设备、方案和分析的可靠性和稳健性,以及 MBW 技术的可靠性。目前的数据将有助于解释肺部疾病患者治疗干预的效果和纵向数据的解释。