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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05124197
Enrollment
81
Registered
2021-11-17
Start date
2020-03-01
Completion date
2021-10-15
Last updated
2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

prone position, mechanical ventilation

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.

Interventions

OTHERprone position

extension of prone position duration

Sponsors

Hôpital Louis Mourier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
plateau pressurethrough 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 pressurethrough 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
arterial blood gasesthrough 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)
positive end-expiratory pressurethrough 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 fractionthrough 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
respiratory compliance systemthrough 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026