NCT05124197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

November 15, 2021

Last Update Submit

November 16, 2021

Conditions

Pressure UlcerRespiratory Distress Syndrome, AcuteHypoxemic Respiratory FailureCOVID-19 Acute Respiratory Distress Syndrome

Keywords

prone positionmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

prone positionOTHER

extension of prone position duration

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult, ICU, COVID-19 related ARDS patients with profound hypoxemia requiring invasive mechanical ventilation and prone position

You may qualify if:

  • 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)

You may not qualify if:

  • transfer to another ICU facility after initial admission (inter-regional regulation of ICU beds' availability)
  • Incomplete or missing medical file
  • Refusal to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

Colombes, 92700, France

Location

Related Publications (7)

  • 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.

    PMID: 23688302BACKGROUND

  • 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.

    PMID: 31197492BACKGROUND

  • 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.

    PMID: 33726819BACKGROUND

  • 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.

    PMID: 24863923BACKGROUND

  • 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.

    PMID: 33034686BACKGROUND

  • 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.

    PMID: 28236174BACKGROUND

  • 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.

    PMID: 35804453DERIVED

MeSH Terms

Conditions

Pressure UlcerRespiratory Distress SyndromeRespiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jean-Damien Ricard, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Intensive Care Medicine, Head ICU

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 17, 2021

Study Start

March 1, 2020

Primary Completion

April 30, 2021

Study Completion

October 15, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)