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Clinical Trials/NCT04402879
NCT04402879CompletedNot Applicable

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

University of Calgary8 sites in 1 country596 target enrollmentStarted: November 10, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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)

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.

Intervention: Prone Positioning (PP) (Procedure)

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.

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ken Kuljit Parhar, MD

Consultant Intensivist & Clinical Assistant Professor

University of Calgary

Study Sites (8)

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