Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE (APPROVE-CARE)

University College Hospital Galway

Status: Terminated

Conditions: Mechanical Ventilation Complication; COVID19; ARDS, Human

Treatments: Procedure: Prone Positioning; Procedure: Standard of care.

Study type: Interventional

Funder types: Other

Identifiers

NCT04347941

APPROVE-CARE-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Prone Positioning

Experimental group

Description:

Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals

Treatment:

Procedure: Prone Positioning

Standard Care

Active Comparator group

Description:

Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.

Treatment:

Procedure: Standard of care.