Extended Prone Position Duration COVID-19-related ARDS: a Retrospective Study

Study Overview
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Brief Summary
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Prone position (PP) is standard of care for mechanically ventilated patients with severe acute respiratory distress syndrome in the intensive care unit (ICU). Recommendations suggest PP durations of at least 16 hours. In 2020, COVID-19 pandemic led to a great number of patients requiring mechanical ventilation and PP in the ICU. Risk of ICU staff viral contamination and work overload led to prolongation of PP duration up to 48 hours. Here investigators report outcomes of prolonged PP sessions in terms of skin complications (pression injuries) and ventilatory improvement.

Detailed Description
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Acute respiratory distress syndrome (ARDS) is a severe condition in which diffuse ventilation/perfusion mismatching and intra-pulmonary shunt are responsible for profound hypoxemia. In patients with severe ARDS, prone position (PP) improves oxygenation and reduces mortality. Recommendations suggest that PP sessions should last at least 16 consecutive hours. Safety concern is mainly related to the risk of pressure injuries. In 2020, COVID-19 pandemic led to a great number of patients requiring mechanical ventilation (MV) and PP in the Intensive Care Units (ICUs) worldwide. In the ICU of Louis Mourier hospital (Colombes, France) investigators decided upon a strategy whereby PP sessions duration was extended up to 48 hours in patients with COVID-19-related ARDS, so as to minimize the number and workload of turning procedures, limit staff exposure to viral contamination, and avoid turning patients during night shifts. Here, investigators aim to report incidence of skin complications (pression injuries) in patients who underwent at least one prolonged PP session. Secondary objective was to evaluate evolution of ventilatory parameters with prolonged PP sessions.

Official Title
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Safety and Efficacy of a Strategy Extending Duration of Prone Position in COVID-19-related ARDS Patients. a Retrospective Monocentric Observational Study

Conditions
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Pressure Ulcer, Respiratory Distress Syndrome, Acute, Hypoxemic Respiratory Failure, COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Other: prone position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID-19 proven by PCR-testing of respiratory specimen Acute respiratory distress syndrome (Berlin definition) requiring invasive mechanical ventilation and prone position at least one session of prolonged prone position (that includes two consecutive nights in prone position) Exclusion Criteria: transfer to another ICU facility after initial admission (inter-regional regulation of ICU beds' availability) Incomplete or missing medical file Refusal to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort of ICU patients with COVID-19 related ARDS requiring at least one extended PP session<br>patients with COVID-19 related ARDS requiring prone position because of profound hypoxemia were applied the investigators' strategy to extend duration of prone position: after being turned prone, they spent at least two complete nights in prone position before being turned to supine position | Other: prone position<br>* extension of prone position duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of skin complications (pressure injuries) | overall and per stage (from stage 1 to stage 4) incidence of pressure injuries | from first prone position session to Day-28 or ICU discharge, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood gases | changes in arterial blood gases (partial pressure in oxygen, carbon dioxide and pH) | through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2) | 
| plateau pressure | teleinspiratory pause pressure | through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2) | 
| driving pressure | plateau minus positive end-expiratory pressure | through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2) | 
| respiratory compliance system | volume over pressure ratio of the respiratory system | through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2) | 
| positive end-expiratory pressure | positive end-expiratory pressure | through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2) | 
| inspired oxygen fraction | inspired oxygen fraction | through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prone position, mechanical ventilation