Clinical trial NCT05124197: Extended Prone Position Duration COVID-19-related ARDS: a Retrospective Study
Official title: Safety and Efficacy of a Strategy Extending Duration of Prone Position in COVID-19-related ARDS Patients. a Retrospective Monocentric Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcer
Respiratory Distress Syndrome, Acute
Hypoxemic Respiratory Failure
COVID-19 Acute Respiratory Distress Syndrome
Keywords: prone position
mechanical ventilation
Lead sponsor: Hôpital Louis Mourier
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult, ICU, COVID-19 related ARDS patients with profound hypoxemia requiring invasive mechanical ventilation and prone position

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of skin complications (pressure injuries)
timeFrame: from first prone position session to Day-28 or ICU discharge, whichever comes first
Secondary outcomes:
measure: arterial blood gases
timeFrame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
measure: plateau pressure
timeFrame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
measure: driving pressure
timeFrame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
measure: respiratory compliance system
timeFrame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
measure: positive end-expiratory pressure
timeFrame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
measure: inspired oxygen fraction
timeFrame: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Damien Ricard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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