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

NCT ID: NCT05124197

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-10-15

Brief Summary

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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

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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.

Conditions

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

Keywords

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prone position mechanical ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

prone position

Intervention Type OTHER

extension of prone position duration

Interventions

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prone position

extension of prone position duration

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Louis Mourier

OTHER

Sponsor Role lead

Responsible Party

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Prof Jean-Damien RICARD

Professor of Intensive Care Medicine, Head ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Damien Ricard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

Colombes, , France

Site Status

Countries

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France

References

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Guerin 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.

Reference Type BACKGROUND
PMID: 23688302 (View on PubMed)

Papazian L, Aubron C, Brochard L, Chiche JD, Combes A, Dreyfuss D, Forel JM, Guerin 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.

Reference Type BACKGROUND
PMID: 31197492 (View on PubMed)

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, Guerin 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.

Reference Type BACKGROUND
PMID: 33726819 (View on PubMed)

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, Guerin 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.

Reference Type BACKGROUND
PMID: 24863923 (View on PubMed)

Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, Francois 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.

Reference Type BACKGROUND
PMID: 33034686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28236174 (View on PubMed)

Walter T, Zucman N, Mullaert J, Thiry I, Gernez C, Roux D, Ricard JD. Extended prone positioning duration for COVID-19-related ARDS: benefits and detriments. Crit Care. 2022 Jul 8;26(1):208. doi: 10.1186/s13054-022-04081-2.

Reference Type DERIVED
PMID: 35804453 (View on PubMed)

Other Identifiers

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HLM_JDR10

Identifier Type: -

Identifier Source: org_study_id