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

Sponsor

Hôpital Louis Mourier (Other)

Overall Status

Completed

CT.gov ID

NCT05124197

Collaborator

(none)

Enrollment

Location

19.5

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure COVID-19 Acute Respiratory Distress Syndrome	Other: prone position

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 Design

Study Type:

Observational

Actual Enrollment :

81 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Oct 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Cohort of ICU patients with COVID-19 related ARDS requiring at least one extended PP session 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 extension of prone position duration

Arm

Intervention/Treatment

Cohort of ICU patients with COVID-19 related ARDS requiring at least one extended PP session

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

extension of prone position duration

Outcome Measures

Primary Outcome Measures

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

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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