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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
NIOD will be implemented on four different parts of the chest walls, 3 minutes for each part and 12 minutes in total per each session. Left and right front and posterior chest walls will be stimulated (Figure1), particularly, on the anterior chest, intercostal spaces 1-2 above nipple line and lateral side of the midclavicular line 1-2 below intercostal spaces. The intensity of the NIOD can be selected between 80-100%, which is prespecified on the machine.
Mean changes in respiratory tidal volume
Tidal volume will be measured by non-invasive 3D system for non-intubated patients and ventilator for intubated patients.
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Changes of blood pressures (mmHg)
Time frame: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Estimated lung volume
lung volume will be measured by mechanical ventilator when patients are on an invasive mechanical ventilator, or 3D non-invasive measuring system when patients are not on an invasive mechanical ventilator (reference: Computerized Medical Imaging and Graphics 70 (2018) 17-28)
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
EtCO2 and its waveform.
Time frame: Baseline: before the procedure, Comparison: two minutes from the beginning of the procedure
Clinical Respiratory severity scores
Use modified Woods Score, which consists of 5 elements including 1) accessory muscle use 2) cyanosis (Y/N), 3) lung air entry, 4) level of contiousness, and 5) wheeze (Y/N). The score scales from 0-10, for which the higher score indicates higher severity of respiratory condition.
Time frame: collected 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Change of heart rates (beat per minute)
Lucy Clayton
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of oxygen saturations (%)
Time frame: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of respiratory rate (times per minute)
Time frame: from the beginning of the intervention till 30 min after the intervention will be extracted from the Electronic Medical Records (i.e., every minutes).
Change of neurological status (i.e., patient comfort level).
Use COMFORT-B Scale. Score scale: 1-35, higher scale indicates that patients is more agitated and uncomfortable.
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Change of level of work of breathing (i.e., no WOB, mild, moderate, and severe).
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.
Lung air distribution
lung air distribution will be measured by using EIT (electrical impedance tomography). The distribution will be examined by area of air distribution which is measured and quantified by EIT.
Time frame: 1) right before the intervention being initiated, 2) right after the end of the intervention (i.e., 12 minutes from 1)), and 3) 30 min after each intervention finished.