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 : Terminated (Enrollment for trial was terminated on January 26, 2021 after a third interim analysis demonstrated that a pre-defined statistical criteria for efficacy were met as part of meta-trial study of awake prone positioning.)
First Posted : April 15, 2020
Results First Posted : December 2, 2021
Last Update Posted : December 2, 2021
|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)|
|Actual Enrollment :||24 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|
|Actual Primary Completion Date :||January 26, 2021|
|Actual Study Completion Date :||January 26, 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 or Death 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 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.
- Length of Time Tolerating Prone Positioning [ Time Frame: 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 [ Time Frame: Immediately before intervention ]Measure of change in oxygenation before intervention in the patients assigned to awake prone positioning
- PaO2/FiO2 Ratio After 1 Hours of Prone Positioning [ Time Frame: During intervention ]Measure of change in oxygenation following patients being placed in the prone position for 1 hour
- SpO2/FiO2 Ratio Measured Before Prone Positioning [ Time Frame: Immediately before intervention ]Measure of oxygenation using pulse oximetry before intervention where ABG not available
- SpO2/FiO2 Ratio After 1 Hour in Prone Positioning [ Time Frame: During Intervention ]Measure of oxygenation 1 hour after intervention where ABG not available
- Number Requiring Increase in Ventilatory Assistance [ Time Frame: 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) [ 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 ]Number of patients who underwent rescue awake prone positioning in control patients by physicians 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
|Galway University Hospital|