Status:
UNKNOWN
Airway Clearance Using Non-Invasive Oscillating Device
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
MedTeq
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed 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 inv...
Eligibility Criteria
Inclusion
- All the patients admitted to the PICU during the study period will be screened. The investigators will not set any restriction regarding the timing of prescription of CPT (i.e., length of PICU stay before screening) for the screening. The investigators will include only if CPT is expected to be used as a management at least for the next 24 hours in the PICU from the time of inclusion. For instance, if CPT will be expected to be discontinued from the management in a day, the investigators will exclude the participants from the inclusion. CPT can be prescribed for airway clearance with any etiology such as atelectasis at the directions of bedside pediatric intensivists in charge on the study date. The investigators will only include patients whose oxygenation is stable (SpO2\>90%) with less than 0.60 of ventilators.
Exclusion
- CPT order will (or is expected to) be discontinued within 24 hours from the inclusion timing.
- CPT is not ordered for airway clearance.
- SpO2 is not stable (SpO2=\<90%) with more than 0.60 of FIO2 for the ventilated patients including patients on NIV, at least for previous 1 hour from the screening.
- SpO2 is not stable (SpO2=\<90%) with more than 0.60 of FIO2 for the patients on HFNC, at least for previous 1 hour from the screening.
- Bradycardia (HR\<80bpm) at any interventions at least for 24 hours prior to the screening.
- Patients with known pneumothorax, osteomyelitis in the PICU admission.
- Known pulmonary hypertension with treatment(s) underway.
- Thoracotomy within 1 month.
- Known recent/unhealed rib fractures.
- Known skin injury of chest wall.
- No obtain of IC.
- Brain death or vegetated states.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03821389
Start Date
June 1 2020
End Date
December 31 2021
Last Update
March 17 2020
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