Evidence map›Paper›PMID 35321918›Full record

Trial reportBMJ (Clinical research ed.)2022

Prone positioning of patients with moderate hypoxaemia due to covid-19: multicentre pragmatic randomised trial (COVID-PRONE).

Michael Fralick, Michael Colacci, Laveena Munshi, Kevin Venus, Lee Fidler, Haseena Hussein, Karen Britto, Rob Fowler, Bruno R da Costa, Irfan Dhalla and 18 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 48 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 11 pooled it
15.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04383613 naunknown statusnot on this map

Prone Positioning for Patients on General Medical Wards With COVID19: A Multicenter Pragmatic Randomized Trial [COVID-PRONE]

TypeinterventionalSponsorUnity Health TorontoRan2020 to 2021Enrolled340ConditionsCovid-19, ARDSArmsProne positioning
NCT05689216 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Efficacy of Timed Awake Prone and Repositioning in Patients With Covid-19-induced Hypoxic Respiratory Failure: a Multi-center, Randomized Controlled Trial.

TypeinterventionalSponsorSecond Affiliated Hospital, Zhejiang University, School of MedicineRan2023 to 2024Enrolled286ConditionsCorona Virus Infection, Hypoxic Respiratory FailureArmsAwake timed prone and repositioning
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 11 syntheses or guidelines pooled it, 107 citations in OpenAlex.

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  18. Prone positioning in ARDS.Intensive care medicine · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors at 14 institutions in 3 countries.

Michael FralickDivision of General Internal Medicine, Sinai Health, Toronto, ON, Canada mike.fralick@mail.utoronto.ca.ORCID 0000-0002-2082-2445
Michael ColacciGeneral Internal Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.
Laveena MunshiMount Sinai Hospital, Interdepartmental Division of Critical Care Medicine, Toronto, ON, Canada.
Kevin VenusUniversity Health Network, Division of General Internal Medicine and Geriatrics, Toronto, ON, Canada.
Lee FidlerDivision of Respirology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Haseena HusseinDepartment of Medicine, William Osler Health System, Brampton, ON, Canada.
Karen BrittoDepartment of Medicine, William Osler Health System, Brampton, ON, Canada.
Rob FowlerUniversity Health Network, Interdepartmental Division of Critical Care Medicine, Toronto, ON, Canada.
Bruno R da CostaThe Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON, Canada.
Irfan DhallaDivision of General Internal Medicine, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.
Richard Dunbar-YaffeDivision of General Internal Medicine and Geriatrics, Sinai Health System and University Health Network, Toronto, ON, Canada.
Leora Branfield DayGeneral Internal Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.
Thomas E MacMillanUniversity Health Network, Division of General Internal Medicine and Geriatrics, Toronto, ON, Canada.
Jonathan ZipurskyDepartment of Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
Travis CarpenterDivision of General Internal Medicine, St Joseph's Health Centre, Unity Health Toronto, ON, Canada.
Terence TangInstitute for Better Health, Trillium Health Partners, Mississauga, ON, Canada.
Amanda CookeDepartment of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Rachel HenselDepartment of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Melissa BreggerDepartment of Medicine, Division of Hospital Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
Alexis GordonDepartment of Medicine, Scarborough Health Network, Scarborough, ON, Canada.
Erin WorndlDepartment of Medicine, Scarborough Health Network, Scarborough, ON, Canada.
Stephanie GoDepartment of Medicine, Humber River Hospital, Toronto, ON, Canada.
Keren MandelzweigDepartment of Medicine, Humber River Hospital, Toronto, ON, Canada.
Lana A CastellucciDepartment of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada.
Daniel TammingUnity Health Toronto, Toronto, ON, Canada.
Fahad RazakDivision of General Internal Medicine, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.
Amol A VermaDivision of General Internal Medicine, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.
COVID Prone Study Investigators
St. Michael's Hospital · CAUniversity Health Network · CAUniversity of Toronto · CABeth Israel Deaconess Medical Center · USHumber River Regional Hospital · CASunnybrook Health Science Centre · CAThe Scarborough Hospital · CAWilliam Osler Health System · CAMount Sinai Hospital · CANorthwestern University · USSinai Health System · CATrillium Health Centre · CAUnity Health TorontoUniversity of Ottawa · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the effectiveness of prone positioning to reduce the risk of death or respiratory failure in non-critically ill patients admitted to hospital with covid-19.

designMulticentre pragmatic randomised clinical trial.

setting15 hospitals in Canada and the United States from May 2020 until May 2021.

participantsEligible patients had a laboratory confirmed or a clinically highly suspected diagnosis of covid-19, needed supplemental oxygen (up to 50% fraction of inspired oxygen), and were able to independently lie prone with verbal instruction. Of the 570 patients who were assessed for eligibility, 257 were randomised and 248 were included in the analysis.

interventionPatients were randomised 1:1 to prone positioning (that is, instructing a patient to lie on their stomach while they are in bed) or standard of care (that is, no instruction to adopt prone position).

main outcome measuresThe primary outcome was a composite of in-hospital death, mechanical ventilation, or worsening respiratory failure defined as needing at least 60% fraction of inspired oxygen for at least 24 hours. Secondary outcomes included the change in the ratio of oxygen saturation to fraction of inspired oxygen.

resultsThe trial was stopped early on the basis of futility for the pre-specified primary outcome. The median time from hospital admission until randomisation was 1 day, the median age of patients was 56 (interquartile range 45-65) years, 89 (36%) patients were female, and 222 (90%) were receiving oxygen via nasal prongs at the time of randomisation. The median time spent prone in the first 72 hours was 6 (1.5-12.8) hours in total for the prone arm compared with 0 (0-2) hours in the control arm. The risk of the primary outcome was similar between the prone group (18 (14%) events) and the standard care group (17 (14%) events) (odds ratio 0.92, 95% confidence interval 0.44 to 1.92). The change in the ratio of oxygen saturation to fraction of inspired oxygen after 72 hours was similar for patients randomised to prone positioning and standard of care.

conclusionAmong non-critically ill patients with hypoxaemia who were admitted to hospital with covid-19, a multifaceted intervention to increase prone positioning did not improve outcomes. However, wide confidence intervals preclude definitively ruling out benefit or harm. Adherence to prone positioning was poor, despite multiple efforts to increase it. Subsequent trials of prone positioning should aim to develop strategies to improve adherence to awake prone positioning. STUDY REGISTRATION: ClinicalTrials.gov NCT04383613.

Indexed as

COVID-19AgedFemaleHospital MortalityHumansHypoxiaMiddle AgedPatient PositioningProne Position

Identifiers

PMID35321918
PMCPMC8941343
OpenAlexW4220724255

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.