CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals

Sponsor

University of Calgary (Other)

Overall Status

Unknown status

CT.gov ID

NCT04402879

Collaborator

Alberta Health services (Other)

596

Enrollment

Locations

Arms

18.7

Anticipated Duration (Months)

149

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Syndrome Coronavirus 2 COVID-19 Acute Respiratory Distress Syndrome ARDS Hypoxemic Respiratory Failure	Procedure: Prone Positioning (PP)	N/A

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

Anticipated Enrollment :

596 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 10, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: 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 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.
No Intervention: Control - usual management The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.

Arm

Intervention/Treatment

Experimental: Prone Positioning (PP)

Procedure: 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 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.

No Intervention: Control - usual management

The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.

Outcome Measures

Primary Outcome Measures

Hospital mortality or discharge to hospice [60 days]
In-hospital mortality or discharge to hospice at Day 60.

Secondary Outcome Measures

Adverse Events and Serious Adverse Events [60 days]
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
Change in SpO2 [60 days]
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).
Hospital free days [60 days]
Number of hospital free days in the 60 days after enrolment.
Admission to ICU [60 days]
Admission to the Intensive Care Unit.
Intubation and mechanical ventilation [60 days]
Patient is intubated and requires mechanical ventilation.
Initiation of non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO). [60 days]
Patient requires non-invasive ventilation (NIV) or high-flow nasal oxygen (HFNO).
Oxygen-free days [60 days]
The number of oxygen-free days at Day 60 (censored at discharge).
In-hospital death (time) [60 days]
Time from admission to all-cause in-hospital death.
Death at 90 days [90 days]
Death at 90 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hospitalized patients with probable COVID-19. 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peter Lougheed Centre (PLC)	Calgary	Alberta	Canada	T1Y 6J4
2	Foothills Hospital Intensive Care Unit	Calgary	Alberta	Canada	T2N 2T9
3	Rockyview General Hospital	Calgary	Alberta	Canada	T2V 1P9
4	South Health Campus	Calgary	Alberta	Canada	T3M 1M4