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Incremental effect of non-invasive oscillating device on chest physiotherapy in critically ill children: a cross-over randomised trial [with consumer summary]
Kawaguchi A, Bernier G, Adler A, Emeriaud G, Jouvet PA
BMJ Open 2020 Oct;10(10):e038648
clinical trial
2/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

INTRODUCTION: 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. METHOD AND ANALYSES: 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 versus 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 delta changes 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT03821389).
Reproduced with permission from the BMJ Publishing Group.

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