Kawaguchi Atsushi, Bernier Gabrielle, Adler Andy, Emeriaud Guillaume, Jouvet Philippe A
Pediatrics, University of Montreal, Montreal, Quebec, Canada.
Pediatrics, University of Ottawa, Children's Hospital Eastern Ontario, Ottawa, Ontario, Canada.
BMJ Open. 2020 Oct 5;10(10):e038648. doi: 10.1136/bmjopen-2020-038648.
Chest physiotherapy (CPT) and intrathoracic percussion ventilation have been recognised as to encourage dislodging the secretions; nonetheless, the tolerance to the procedure and its efficiency have not been proven to be sufficient.
This study aims to examine the tolerance, feasibility and physiological effects in airway clearance by using a novel extrathoracic non-invasive oscillating transducer device (NIOD) in critically ill children. A two-stage cross-over randomised controlled study in a paediatric intensive care unit in a Canadian Academic Children's Hospital will be applied. Children under 24 months old, for whom CPT is prescribed for airway clearance, will be included. The study consists of two stages; (1) Stage 1 'Frequency Level': we will apply two different frequencies of the NIOD (40 Hz vs 60 Hz) for 12 min each, on each patient 3 hours apart, and (2) Stage 2 'NIOD versus CPT': we will implement NIOD and CPT alternatingly for 3 hours apart. The order of the procedures will be randomly allocated for each case. We will compare the average Δchanges of tidal lung volume measured by a 3D imaging system and regional lung functions using electrical impedance tomography, between the two different frequencies and between the NIOD periods and the CPT periods. We will also examine tolerance by seeing COMFORT Scales and related complications during the procedures. We estimate necessary sample size as 6 for each arm (Total 12 cases) for stage 1 and 48 cases for Stage 2, with power of 0.8 and alpha of 0.05.
This study has been approved by the Health Research Ethics Board of University of Montreal, Canada (REB number: 2020-2471). We will disseminate our findings through peer-reviewed publications and conference presentations in paediatric or/and critical care fields.
ClinicalTrials.gov Registry (NCT03821389).
胸部物理治疗（CPT）和胸内叩击通气已被认为有助于促进分泌物排出；然而，该操作的耐受性及其有效性尚未被证明是足够的。
本研究旨在通过使用一种新型的胸外无创振荡换能器装置（NIOD），检验危重症儿童气道清除的耐受性、可行性和生理效应。将在加拿大一所学术儿童医院的儿科重症监护病房进行一项两阶段交叉随机对照研究。将纳入24个月以下因气道清除而开具CPT处方的儿童。该研究包括两个阶段：（1）第一阶段“频率水平”：我们将对每位患者每隔3小时分别应用两种不同频率的NIOD（40Hz与60Hz），每次12分钟；（2）第二阶段“NIOD与CPT对比”：我们将每隔3小时交替实施NIOD和CPT。每个病例的操作顺序将随机分配。我们将比较在两种不同频率之间以及在NIOD阶段和CPT阶段之间，通过三维成像系统测量的潮气量平均变化以及使用电阻抗断层扫描的区域肺功能。我们还将通过观察操作过程中的舒适度量表和相关并发症来检验耐受性。我们估计第一阶段每组所需样本量为6例（共12例），第二阶段为48例，检验效能为0.8，α为0.05。
本研究已获得加拿大蒙特利尔大学健康研究伦理委员会批准（伦理审查委员会编号：2020 - 2471）。我们将通过儿科或/和重症监护领域的同行评审出版物和会议报告来传播我们的研究结果。
ClinicalTrials.gov注册库（NCT03821389）。
