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NCT Number: NCT05124197

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

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.

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Key information

Conditions

Pressure Ulcer COVID-19 Acute Respiratory Distress Syndrome Hypoxemic Respiratory Failure Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Acute Respiratory Insufficiency Respiratory Tract Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

Colombes, 92700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone position

Other

extension of prone position duration

Primary outcomes

  1. Incidence of skin complications (pressure injuries)

    Time frame: 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 outcomes

  1. arterial blood gases

    Time frame: 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)

  2. plateau pressure

    Time frame: 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

  3. driving pressure

    Time frame: 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

  4. respiratory compliance system

    Time frame: 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

  5. positive end-expiratory pressure

    Time frame: 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

  6. inspired oxygen fraction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hôpital Louis Mourier

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 17, 2021
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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