A Prospective Randomized Trial of Prone Positioning Versus Usual Care for Patients With Do-not-intubate Goals of Care and Hypoxemic Respiratory Failure During the Coronavirus SARS-CoV-2 (COVID-19) Pandemic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Calgary
- Enrollment
- 596
- Locations
- 8
- Primary Endpoint
- Hospital mortality or discharge to hospice
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospitalized patients with probable COVID-
- •Probable is defined as Influenza like illness (ILI) symptoms OR confirmed COVID-19 exposure AND COVID-19 testing performed. ILI is defined as any one of the following symptoms including: fever, new or worsening cough, coryza, new or worsening dyspnea, or sore throat.
- •Goals of care are do-not-intubate (R3 or M1/M2 in Alberta).
- •Need for oxygen ≥2 L to maintain SpO2 ≥92%. If the patient is on long-term oxygen, the O2 requirements must be ≥2 L above their baseline.
- •Patient can be positioned to and from prone to supine with minimal assistance (maximum one person assistance).
Exclusion Criteria
- •Decreased level of consciousness (Glasgow Coma Scale < 10) or precluding ability to self-reposition.
- •Hemodynamic instability (Systolic Blood Pressure < 90 mmHg and or Lactate >5 mmol/L or HR >120, not responsive to fluid resuscitation).
- •Complete bowel obstruction.
- •Active upper gastrointestinal bleeding.
- •Poor neck mobility or patient inability to lie prone comfortably.
- •Unstable spine, femur, or pelvic fractures.
- •Pregnancy - third trimester.
- •Full resuscitation status including ICU and willingness to accept invasive mechanical ventilation (i.e. R1/R2 goals of care).
- •Imminent palliation or end of life expected on admission (i.e. C1/C2 goals of care).
Arms & Interventions
Prone Positioning (PP)
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.
Intervention: Prone Positioning (PP) (Procedure)
Control - usual management
The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.
Outcomes
Primary Outcomes
Hospital mortality or discharge to hospice
Time Frame: 60 days
In-hospital mortality or discharge to hospice at Day 60.
Secondary Outcomes
- Change in SpO2(60 days)
- Hospital free days(60 days)
- Adverse Events and Serious Adverse Events(60 days)
- Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).(60 days)
- In-hospital death (time)(60 days)
- Death at 90 days(90 days)
- Oxygen-free days(60 days)
- Admission to ICU(60 days)
- Intubation and mechanical ventilation(60 days)
Investigators
Ken Kuljit Parhar, MD
Consultant Intensivist & Clinical Assistant Professor
University of Calgary