The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19.
As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients. The objective of this trial is to determine whether PP improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19. Patients randomized to the intervention arm will continue with prone positioning until study inclusion criteria are no longer met, discharge from hospital, day 60 in hospital, or until death or discharge to hospice. Daily assessments will occur until day 60 or until the patient is discharged from hospital or is deceased. The investigators anticipate recruitment to be completed within 12 months of starting the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
596
The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day until the occurrence of a primary outcome event or hospital discharge. The target duration (dose) of PP is \> 8 hours per day for up to 60 days, or until oxygen requirements are \< 2 L per minute or \< 2 L per minute above baseline home oxygen requirements.
Peter Lougheed Centre (PLC)
Calgary, Alberta, Canada
RECRUITINGFoothills Hospital Intensive Care Unit
Calgary, Alberta, Canada
RECRUITINGRockyview General Hospital
Calgary, Alberta, Canada
NOT_YET_RECRUITINGSouth Health Campus
Calgary, Alberta, Canada
NOT_YET_RECRUITINGHospital mortality or discharge to hospice
In-hospital mortality or discharge to hospice at Day 60.
Time frame: 60 days
Adverse Events and Serious Adverse Events
An Adverse Event (AE) is any unfavourable or other finding (including clinically significant laboratory tests), symptom or disease occurring during the during of the study, whether or not it is considered to be related to the medicinal (investigational) product, not explicitly classified elsewhere in this protocol, and whether or not it is expected. A Serious Adverse Event (AE) is any unfavourable medical finding (including clinically significant laboratory tests) at any dose that: * Results in death (primary outcome) * Is life threatening * Results in persistent of significant disability or incapacity * Requires in in-patient hospitalisation or prolongation of Hospitalisation
Time frame: 60 days
Change in SpO2
Change in SpO2 during each PP session (SpO2 in prone position - SpO2 prior to prone positioning). Clinicians will be asked to record this change for the first proning session per shift (for 12 hour shifts this will result in 2 proning sessions being documented per 24 hour period, and for 8 hour shifts this will result in 3 proning sessions being documented per 24 hour period).
Time frame: 60 days
Hospital free days
Number of hospital free days in the 60 days after enrolment.
Time frame: 60 days
Admission to ICU
Admission to the Intensive Care Unit.
Time frame: 60 days
Intubation and mechanical ventilation
Patient is intubated and requires mechanical ventilation.
Time frame: 60 days
Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Time frame: 60 days
Oxygen-free days
The number of oxygen-free days at Day 60 (censored at discharge).
Time frame: 60 days
In-hospital death (time)
Time from admission to all-cause in-hospital death.
Time frame: 60 days
Death at 90 days
Death at 90 days.
Time frame: 90 days
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