Pressure UlcerNCT05124197
Extended Prone Position Duration COVID-19-related ARDS: a Retrospective Study
An observational study of Pressure Ulcer and Respiratory Distress Syndrome, Acute, run by Hôpital Louis Mourier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Respiratory Distress Syndrome, Acute, Hypoxemic Respiratory Failure
- What is being tested?
- prone position
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 15 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult, ICU, COVID-19 related ARDS patients with profound hypoxemia requiring invasive mechanical ventilation and prone position
Who may be able to join
- 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)
Who cannot join
- transfer to another ICU facility after initial admission (inter-regional regulation of ICU beds' availability)
- Incomplete or missing medical file
- Refusal to consent
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris
Colombes, 92700
About this study
Official title: Safety and Efficacy of a Strategy Extending Duration of Prone Position in COVID-19-related ARDS Patients. a Retrospective Monocentric Observational 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.
Read the 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.
- Conditions
- Pressure Ulcer, Respiratory Distress Syndrome, Acute, Hypoxemic Respiratory Failure, COVID-19 Acute Respiratory Distress Syndrome
- Being tested
- prone position
- Keywords
- prone position, mechanical ventilation
- Medical subject headings
- Pressure Ulcer, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionOther
extension of prone position duration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of skin complications (pressure injuries)
overall and per stage (from stage 1 to stage 4) incidence of pressure injuries
Measured: from first prone position session to Day-28 or ICU discharge, whichever comes first
Secondary outcomes (6)
arterial blood gases
changes in arterial blood gases (partial pressure in oxygen, carbon dioxide and pH)
Measured: 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
teleinspiratory pause pressure
Measured: 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
plateau minus positive end-expiratory pressure
Measured: 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
volume over pressure ratio of the respiratory system
Measured: 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
positive end-expiratory pressure
Measured: 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
inspired oxygen fraction
Measured: through each prone position session, that lasts an average of 39 hours: before session (T0), during session (T1) and immediately after session (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Mar 2020
- Primary completion30 Apr 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Louis Mourier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Jean-Damien RICARD, Hôpital Louis Mourier
- Investigators
- Jean-Damien Ricard, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124197
- Sponsor's protocol ID
- HLM_JDR10
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23688302Papazian 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.
PubMed 31197492Nasa 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.
PubMed 33726819Sud 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.
PubMed 24863923Labeau 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.
PubMed 33034686Gaudry 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.
PubMed 28236174Walter 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.
PubMed 35804453
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Strategy Extending Duration of Prone Position in COVID-19-related ARDS Patients. a Retrospective Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT05124197
- Acronym / sponsor ID
- HLM_JDR10
- Conditions
- Pressure Ulcer, Respiratory Distress Syndrome, Acute, Hypoxemic Respiratory Failure, COVID-19 Acute Respiratory Distress Syndrome
- Keywords
- prone position, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hôpital Louis MourierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of ICU patients with COVID-19 related ARDS requiring at least one extended PP session | – | Other: prone positionpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult, ICU, COVID-19 related ARDS patients with profound hypoxemia requiring invasive mechanical ventilation and prone position
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- transfer to another ICU facility after initial admission (inter-regional regulation of ICU beds' availability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prone positionextension of prone position duration | Other | Cohort of ICU patients with COVID-19 related ARDS requiring at least one extended PP session |
Primary outcome
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
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Background: PubMed 23688302Guerin 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.
- Background: PubMed 31197492Papazian 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.
- Background: PubMed 33726819Nasa 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.
- Background: PubMed 24863923Sud 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.
- Background: PubMed 33034686Labeau 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.
- Background: PubMed 28236174Gaudry 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.
- Derived from this study: PubMed 35804453Walter 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.
- Individual participant dataSharing planned: No
Related trials for Pressure Ulcer
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Damien Ricard, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer and Respiratory Distress Syndrome, Acute, run by Hôpital Louis Mourier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of skin complications (pressure injuries) (time frame: from first prone position session to Day-28 or ICU discharge, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05124197, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.