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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124197
• Other study ID #: HLM_JDR10
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: November 2021
• Source: Hôpital Louis Mourier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 15, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Hypoxemic Respiratory Failure
• Pressure Ulcer
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Acute
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Syndrome

Intervention

Other:
• prone position
extension of prone position duration

Locations

Country	Name	City	State
France	Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Louis Mourier

Country where clinical trial is conducted

France, 

References & Publications (6)

Gaudry S, Tuffet S, Lukaszewicz AC, Laplace C, Zucman N, Pocard M, Costaglioli B, Msika S, Duranteau J, Payen D, Dreyfuss D, Hajage D, Ricard JD. Prone positioning in acute respiratory distress syndrome after abdominal surgery: a multicenter retrospective study : SAPRONADONF (Study of Ards and PRONe position After abDOmiNal surgery in France). Ann Intensive Care. 2017 Dec;7(1):21. doi: 10.1186/s13613-017-0235-z. Epub 2017 Feb 24. — View Citation

Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20. — View Citation

Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, François G, Honore PM, Jankovic R, Khanna AK, Llaurado-Serra M, Lin F, Rose L, Rubulotta F, Saager L, Williams G, Blot SI; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Feb;47(2):160-169. doi: 10.1007/s00134-020-06234-9. Epub 2020 Oct 9. Erratum in: Intensive Care Med. 2021 Apr;47(4):503-520. — View Citation

Nasa P, Azoulay E, Khanna AK, Jain R, Gupta S, Javeri Y, Juneja D, Rangappa P, Sundararajan K, Alhazzani W, Antonelli M, Arabi YM, Bakker J, Brochard LJ, Deane AM, Du B, Einav S, Esteban A, Gajic O, Galvagno SM Jr, Guérin C, Jaber S, Khilnani GC, Koh Y, Lascarrou JB, Machado FR, Malbrain MLNG, Mancebo J, McCurdy MT, McGrath BA, Mehta S, Mekontso-Dessap A, Mer M, Nurok M, Park PK, Pelosi P, Peter JV, Phua J, Pilcher DV, Piquilloud L, Schellongowski P, Schultz MJ, Shankar-Hari M, Singh S, Sorbello M, Tiruvoipati R, Udy AA, Welte T, Myatra SN. Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care. 2021 Mar 16;25(1):106. doi: 10.1186/s13054-021-03491-y. — View Citation

Papazian L, Aubron C, Brochard L, Chiche JD, Combes A, Dreyfuss D, Forel JM, Guérin C, Jaber S, Mekontso-Dessap A, Mercat A, Richard JC, Roux D, Vieillard-Baron A, Faure H. Formal guidelines: management of acute respiratory distress syndrome. Ann Intensive Care. 2019 Jun 13;9(1):69. doi: 10.1186/s13613-019-0540-9. Review. — View Citation

Sud S, Friedrich JO, Adhikari NK, Taccone P, Mancebo J, Polli F, Latini R, Pesenti A, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L, Guérin C. Effect of prone positioning during mechanical ventilation on mortality among patients with acute respiratory distress syndrome: a systematic review and meta-analysis. CMAJ. 2014 Jul 8;186(10):E381-90. doi: 10.1503/cmaj.140081. Epub 2014 May 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of skin complications (pressure injuries)	overall and per stage (from stage 1 to stage 4) incidence of pressure injuries	from first prone position session to Day-28 or ICU discharge, whichever comes first
Secondary	arterial blood gases	changes in arterial blood gases (partial pressure in oxygen, carbon dioxide and pH)	through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
Secondary	plateau pressure	teleinspiratory pause pressure	through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
Secondary	driving pressure	plateau minus 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)
Secondary	respiratory compliance system	volume over pressure ratio of the respiratory system	through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
Secondary	positive end-expiratory pressure	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)
Secondary	inspired oxygen fraction	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)