Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE (APPROVE-CARE)
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|ClinicalTrials.gov Identifier: NCT04347941|
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : August 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|ARDS, Human Mechanical Ventilation Complication COVID19||Procedure: Prone Positioning Procedure: Standard of care.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE|
|Actual Study Start Date :||July 11, 2020|
|Estimated Primary Completion Date :||June 11, 2021|
|Estimated Study Completion Date :||September 11, 2021|
Experimental: Prone Positioning
Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals
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
Active Comparator: Standard Care
Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.
Procedure: Standard of care.
Standard of care. Prone positioning may be administered as a rescue therapy
- The effect of prone positioning on requirement for invasive mechanical ventilation in patients with COVID 19 induced respiratory failure. [ Time Frame: Up to 28 days post randomisation ]A measure of effect of awake prone positioning in reducing requirement for invasive mechanical ventilation.
- Length of time tolerating prone positioning [ Time Frame: Daily during intervention up to 28 days post randomisation ]Total time spent in prone and supine position as recorded by nurse
- PaO2/FiO2 measured before prone positioning [ Time Frame: Immediately before intervention ]Measure of change in oxygenation before intervention
- PaO2/FiO2 ratio after 1 hours of prone positioning [ Time Frame: During intervention ]Measure of change in oxygenation following intervention
- SpO2/FiO2 ratio measured before prone positioning [ Time Frame: Immediately before intervention ]Measure of change in oxygenation using pulse oximetry before intervention where ABG not available
- SpO2/FiO2 ratio after 1 hours of prone positioning [ Time Frame: During Intervention ]Measure of change in oxygenation before intervention where ABG not available
- Number requiring increase in ventilatory assistance (CPAP+BIPAP+IMV etc) [ Time Frame: Up to 28 days post randomisation ]Escalation of ventilatory support
- Work of breathing assessment (Respiratory distress scale) [ Time Frame: 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 [ Time Frame: During intervention ]Substudy examining use of bioimpedance as a surrogate measure of lung edema following prone positioning
- Use of awake prone positioning as a rescue intervention in control patients [ Time Frame: Up to 28 days post randomisation ]Rescue awake prone positioning in control patients in response to hypoxia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347941
|Contact: Bairbre A McNicholas, MB BCh PhDfirstname.lastname@example.org|
|Contact: David Cosgrave, MB BCh FARSIemail@example.com|
|Galway University Hospital||Recruiting|
|Galway University Hospital||Recruiting|
|Contact: Bairbre A McNicholas, MB BCh BAO PhD MRCPI FJFICMI 353838624777 firstname.lastname@example.org|
|Contact: John G Laffey, MD 35391495662 email@example.com|