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

Completed

• Conditions: Respiratory Distress Syndrome, Acute; Hypoxemic Respiratory Failure; Pressure Ulcer; COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Other: prone position

• Registration Number: NCT05124197
• Lead Sponsor: Hôpital Louis Mourier

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.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-10-15
• Status Verified: 2021-11
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-11-17
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of ICU patients with COVID-19 related ARDS requiring at least one extended PP session	prone position	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris; 🇫🇷 Colombes, France