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| Name | Class |
|---|---|
| Alberta Health services | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prone Positioning (PP) | Experimental | 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. |
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| Control - usual management | No Intervention | The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone Positioning (PP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality or discharge to hospice | In-hospital mortality or discharge to hospice at Day 60. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Parhar, MD, MSc | University of Calgary | Principal Investigator |
| Jason Weatherald, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Lougheed Centre (PLC) | Calgary | Alberta | T1Y 6J4 | Canada | ||
| Foothills Hospital Intensive Care Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34425072 | Derived | Weatherald J, Norrie J, Parhar KKS. Awake prone positioning in COVID-19: is tummy time ready for prime time? Lancet Respir Med. 2021 Dec;9(12):1347-1349. doi: 10.1016/S2213-2600(21)00368-4. Epub 2021 Aug 20. No abstract available. |
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This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.
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| 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). | 60 days |
| Hospital free days | Number of hospital free days in the 60 days after enrolment. | 60 days |
| Admission to ICU | Admission to the Intensive Care Unit. | 60 days |
| Intubation and mechanical ventilation | Patient is intubated and requires mechanical ventilation. | 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). | 60 days |
| Oxygen-free days | The number of oxygen-free days at Day 60 (censored at discharge). | 60 days |
| In-hospital death (time) | Time from admission to all-cause in-hospital death. | 60 days |
| Death at 90 days | Death at 90 days. | 90 days |
| Calgary |
| Alberta |
| T2N 2T9 |
| Canada |
| Rockyview General Hospital | Calgary | Alberta | T2V 1P9 | Canada |
| South Health Campus | Calgary | Alberta | T3M 1M4 | Canada |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012128 | Respiratory Distress Syndrome |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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