Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

Not Applicable

Terminated

Conditions: ARDS, Human
Mechanical Ventilation Complication
COVID19

Interventions: Procedure: Prone Positioning
Procedure: Standard of care.

Registration Number: NCT04347941

Lead Sponsor: University College Hospital Galway

Brief Summary: Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.

Detailed Description: Prone positioning (PP) is an adjunctive therapy used that has been proven to save lives in sedated patients with confirmed moderate-severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (MV). PP involves placing patients in the prone, i.e. face down position for time periods of up to 16 hours per day. PP promotes lung homogeneity, improves gas exchange and respiratory mechanics permitting reduction of ventilation intensity, and reducing ventilator-induced lung injury (VILI).

Maintaining self-ventilation is associated with increased aeration of dependent lung regions, less need for sedation, improved cardiac filling and removes the risk of VILI, and so is an important therapeutic goal in hypoxic patients. The use of PP in awake self-ventilating patients with COVID-19 induced acute hypoxic respiratory failure (AHRF) and/or ARDS could improve gas exchange and reduce the need for invasive MV, but has not been studied outside of case series.

However, an increase in oxygenation does not necessarily reduce the risk of invasive MV. PP has significant attached risks such as causing pressure sores in patients, PP is uncomfortable for some patients, it increases nursing workload, and if ineffective could hinder the delivery of other (effective) medical care. Hence there is a need to determine if PP of awake patients is effective in reducing the need for invasive MV. This multi-centre, open label, randomized controlled study of COVID-19 induced AHRF/ARDS will determine if PP reduces the need for mechanical ventilation.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Suspected or confirmed COVID19 infection
Bilateral Infiltrates on CXR
SpO2 <94% on FiO2 40% by either venturi facemask or high flow nasal cannula
RR <40
Written informed consent

Exclusion Criteria

Age <18
Uncooperative or likely to be unable to lie on abdomen for 16 hours
Receiving comfort care only
Multi-organ failure
RR>40
Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy >20/40 gestation, severe brain injury).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone Positioning	Prone Positioning	Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals
Standard Care	Standard of care.	Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.

Primary Outcome Measures

Name	Time	Method
The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure.	Up to 28 days post randomisation	A measure of effect of awake prone positioning in patients with confirmed or suspected COVID-19 acute hypoxemic respiratory failure undergoing supplemental oxygen via high flow nasal cannular oxygen on reducing requirement for invasive mechanical ventilation or death. Outcome measure is calculated as a count of the number of patients who went onto require invasive mechanical ventilation or died up to 28 days post randomization.

Secondary Outcome Measures

Name	Time	Method
PaO2/FiO2 Ratio After 1 Hours of Prone Positioning	During intervention	Measure of change in oxygenation following patients being placed in the prone position for 1 hour
SpO2/FiO2 Ratio After 1 Hour in Prone Positioning	During Intervention	Measure of oxygenation 1 hour after intervention where ABG not available
Length of Time Tolerating Prone Positioning	Daily during intervention up to 14 days post randomisation	description of duration of prone positioning in hours per day from day 0 to day 14 in trial
PaO2/FiO2 Ratio Measured Before Prone Positioning	Immediately before intervention	Measure of change in oxygenation before intervention in the patients assigned to awake prone positioning
Number Requiring Increase in Ventilatory Assistance	Up to 28 days post randomisation	Number of patients in each group requiring an increase in the respiratory support from baseline high flow nasal cannula oxygen post randomization up to 28 days later, defined as need for continuous positive airway pressure (CPAP), bilevel positive airway pressure (biPAP)
Work of Breathing Assessment (Respiratory Distress Scale)	Immediately before and during intervention	Measure of work of breathing in COVID-19 based on Oxygen Delivery Device, Oxygen Saturation and respiratory rate and accessory muscle use with 0-3 Mild, 4-6 Moderate and 7-10 Severe
Changes in Bioimpedance Measures of Lung Edema in Patients in PP	During intervention	Substudy examining use of bioimpedance as a surrogate measure of lung edema following prone positioning
SpO2/FiO2 Ratio Measured Before Prone Positioning	Immediately before intervention	Measure of oxygenation using pulse oximetry before intervention where ABG not available
Use of Awake Prone Positioning as a Rescue Intervention in Control Patients	Up to 28 days post randomisation	Number of patients who underwent rescue awake prone positioning in control patients by physicians in response to hypoxia