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

ARDS, Human
Mechanical Ventilation Complication

Procedure: Prone Positioning

Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 <94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 >94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula

Procedure: Standard of care.

Standard of care. Prone positioning may be administered as a rescue therapy

Eligibility Criteria

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).

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A

Galway University Hospital
Galway, Ireland

University College Hospital Galway
NCT Number
MeSH Terms
Respiratory Insufficiency
Respiratory Distress Syndrome