There is one clinical trial.
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 care unit (ICU). It is a challenge to provide consistent care in this situation of high demand and potential staff shortage in ICU. Also, the investigators need to reduce unnecessary exposure of the providers to the virus. This study aims to examine the impact of care using a non-invasive oscillating device (NIOD) for chest physiotherapy in the care of mechanically ventilated patients with COVID-19. METHODS Objective: To explore if a NIOD performed by non-specialized personnel is not inferior to the standard Chest PhysioTherapy (CPT) in the care of COVID-19. Design: A Pilot Multicenter Prospective Crossover Randomized Study. Setting: Two ICUs in Canadian Academic Hospitals (CHU Sainte Justine and Montreal General Hospital) Patients: All the mechanically ventilated patients admitted to the two ICUs, and CPT ordered by the responsible physician, with COVID-19 infection during the study period. Procedure: The investigators will implement NIOD and CPT alternatingly for 3 hours apart over 3 hours. We will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, Intermittent Positive Pressure Ventilation (IPPV), suctioning (e.g., oral or nasal), or changing the ventilator settings or modality can be provided at the direction of bedside intensivists in charge. The order of the procedures (i.e. NIOD or CPT) will be randomly allocated. Measurements and Analyses: The primary outcome measure is the oxygenation level before and after the procedure (SpO2/FIO2 (SF) ratio). For the cases with Invasive ventilation and non-invasive ventilation, the investigators will also document expiratory tidal volume, vital signs, and any related complications such as vomiting, desaturations, or unexpected extubations. The investigators will collect the data before, 10 minutes after, and 30 minutes after the procedure. Sample Size: The investigators estimate the necessary sample size as 25 for each arm (Total 50 cases), with a power of 0.90, alfa of 0.05, with the non-inferiority design. FUTURE CONSIDERATIONS This randomized pilot study will be considered a running phase if the investigators can/should undertake the RCT which should follow without significant modification of the methods.
Description: Difference before the procedure and 10 minutes from the end of the procedureMeasure: SpO2/FIO2 Ratio Time: 10 minutes and 30 minutes from the end of the procedure
Description: Changes in valuesMeasure: Blood pressures Time: 10 minutes and 30 minutes from the end of the procedure
Description: Changes in valuesMeasure: Heart rates Time: 10 minutes and 30 minutes from the end of the procedure
Description: Changes in valuesMeasure: Respiratory rate Time: 10 minutes and 30 minutes from the end of the procedure
Description: Changes in valuesMeasure: Body temperature Time: 10 minutes and 30 minutes from the end of the procedure
Description: Changes in values (0 to 10, worse outcome is 10)Measure: Modified Wood Clinical Asthma Score (m-WCAS) Time: 10 minutes and 30 minutes from the end of the procedure
Description: Changes in volume.Measure: Expiratory tidal lung volume. Time: 10 minutes and 30 minutes from the end of the procedure
Description: Changes in values and blood gas parameters.Measure: End-tidal CO2 Time: 10 minutes and 30 minutes from the end of the procedure
Description: Changes in scoresMeasure: Clinical Respiratory severity scores. Time: 10 minutes and 30 minutes from the end of the procedure
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports