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Clinical Trial Summary

This study aims to examine the tolerance, feasibility, and physiological effects in airway clearance by using a novel non-invasive oscillating transducer device (NIOD, FrequencerTM) in critically ill children. The project is two years long with two separate stages of investigation. This study specifically examines different frequencies of NIOD to find the best frequency on patients outcomes.


Clinical Trial Description

Airway obstruction due to excessive production of secretion in small children especially those with bronchiolitis is a critical problem in the clinical management. Chest physiotherapy (CPT) and an invasive positive percussion ventilation (IPPV) have been recognized as to encourage dislodging the secretions; nonetheless, the tolerance to the procedure and its efficiency have not been proved to be sufficient. This study aims to examine the tolerance, feasibility, and physiological effects in airway clearance by using a novel non-invasive oscillating transducer device (NIOD) in critically ill children. The study will be prospective Crossover Randomized Study in a Pediatric Intensive Care Unit in a Canadian Academic Children's Hospital. We will target children less than 24-month-old, for whom CPT is prescribed for airway clearance with or without atelectasis. We will apply two different frequencies of NIOD (i.e. 40 and 60Hz) for 3 minutes each, on each patient 3 hours apart. The investigators will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, IPPV, suctioning (e.g., oral or nasal), or changing the ventilator settings or modality (i.e., increasing PEEP or changing the nasal mask to total face CPAP) can be provided at the direction of bedside pediatric intensivists in charge. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03821389
Study type Interventional
Source St. Justine's Hospital
Contact Atsushi Kawaguchi
Phone 5149124247
Email atsushi@ualberta.ca
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date June 1, 2020
Completion date December 31, 2021

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