Status:
UNKNOWN
Lung Recruitment Device for COVID-19
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Dymedso Inc.
Réseau de Recherche en Santé Respiratoire du Québec
Conditions:
COVID-19
Physiotherapy
Eligibility:
All Genders
Phase:
NA
Brief Summary
INTRODUCTION As there is no specific cure in the treatment of COVID-19 at this moment of the pandemic, supportive management including mechanical ventilation is the core management in an intensive car...
Detailed Description
1. BACKGROUND During COVID-19 pandemic, although the proportion of severe or fatal cases may vary by location, 15-30% of hospitalized patients were admitted to the intensive care unit in Italy and Chi...
Eligibility Criteria
Inclusion
- All the patients admitted to the ICUs during the study period will be screened. We will not set any restrictions regarding the timing of the prescription of CPT (i.e., length of ICU stay before screening) for the screening. We will include only if CPT is expected to be used as management at least for the next 24 hours in the ICUs from the time of inclusion. For instance, if CPT will be expected to be discontinued from the management in a day, we will exclude them from the inclusion. CPT can be prescribed for airway clearance with any etiology such as atelectasis at the directions of bedside intensivists in charge of the study date.
- Specific Inclusion criteria
- Patients diagnosed as COVID-19
- Patents strongly suspected its infection and the result of virological testing is pending as of screening.
- Patients with any type of mechanical ventilation (i.e., Invasive, non-invasive, high flow nasal therapy)
- Patients are on standard oxygen by mask or nasal cannula and the FiO2 provided can be measurable.
- Patients who are on respiratory monitoring at least SpO2 can be continuously measurable.
- Exclusion Criteria:
- CPT order will (or is expected to) be discontinued within 12 hours from the inclusion timing. This may include potential discharge from the unit.
- CPT is not ordered for airway clearance.
- SpO2 is not stable (SpO2=\<80%) with more than 0.60 of FIO2 for ventilated patients including patients on NIV, at least for the previous 1 hour from the screening.
- SpO2 is not stable (SpO2=\<80%) with more than 0.60 of FIO2 for the patients on HFNC, at least for the previous 1 hour from the screening.
- Bradycardia (HR\<50bpm) at any intervention at least 24 hours before the screening.
- Patients with known pneumothorax, osteomyelitis at ICU admission.
- Thoracotomy within 1 month from the admission date.
- Known recent/unhealed rib fractures.
- Known skin injury of the chest wall.
- No, obtain of IC.
- Brain death or vegetated states.
Exclusion
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04361435
Start Date
May 1 2020
End Date
December 31 2020
Last Update
April 28 2020
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