Evidence map›Paper›PMID 34425070›Full record

Trial reportThe Lancet. Respiratory medicine2021

Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial.

Stephan Ehrmann, Jie Li, Miguel Ibarra-Estrada, Yonatan Perez, Ivan Pavlov, Bairbre McNicholas, Oriol Roca, Sara Mirza, David Vines, Roxana Garcia-Salcido and 12 more

10 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Respiratory medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 210 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
210citing papers in PubMed, 20 pooled it
51.4field-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.

NCT04325906 nacompletednot on this map

Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS

TypeinterventionalSponsorRush University Medical CenterRan2020 to 2021Enrolled224ConditionsProne Positioning, High Flow Nasal Cannula, Acute Respiratory Distress Syndrome, Corona Virus InfectionArmshigh flow nasal cannula (HFNC), Prone positioning (PP)
NCT04347941 naterminatednot on this map

Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

TypeinterventionalSponsorUniversity College Hospital GalwayRan2020 to 2021Enrolled24ConditionsARDS, Human, Mechanical Ventilation Complication, COVID19ArmsProne Positioning, Standard of care.
NCT04358939 nacompletednot on this map

Evaluation of Prone Position in Conscious Patients on Nasal High-flow Oxygen Therapy for COVID-19 Disease Induced Acute Respiratory Distress Syndrome

TypeinterventionalSponsorUniversity Hospital, ToursRan2020 to 2021Enrolled405ConditionsAcute Respiratory Distress Syndrome, COVID-19ArmsProne decubitus
NCT04391140 naunknown statusnot on this map

Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS

TypeinterventionalSponsorHospital Universitari Vall d'Hebron Research InstituteRan2020 to 2021Enrolled248ConditionsCOVID, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory FailureArmsProne position
NCT04395144 nacompletednot on this map

Randomized-controlled Trial of HFNC Alone vs HFNC and Awake Self-proning for Treatment of Severe COVID-19

TypeinterventionalSponsorHôpital de VerdunRan2020 to 2021Enrolled13ConditionsCoronavirus Infection, COVID, Severe Acute Respiratory Syndrome, Respiratory FailureArmsAwake Prone Positioning, Standard care
NCT04477655 nacompletednot on this map

Prone Positioning in Non-intubated Patients With Severe COVID-19: a Randomized Controlled Trial

TypeinterventionalSponsorHospital Civil de GuadalajaraRan2020 to 2021Enrolled430ConditionsCovid19ArmsAwake prone positioning, Standard oxygen therapy
NCT05083130 nacompletednot on this mapstarted 2022, after this paper: background citation

Evaluation of Awake Prone Positioning Effectiveness in Moderate to Severe COVID-19

TypeinterventionalSponsorOxford University Clinical Research Unit, VietnamRan2022 to 2023Enrolled93ConditionsCOVID-19, SARS-CoV2 Infection, COVID-19 Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory FailureArmsa wake prone positioning
NCT05512585 nacompletednot on this mapstarted 2022, after this paper: background citation

A Physiological Study to Assess the Effects of Awake Prone Positioning in Healthy Volunteers Under Different Respiratory Support: A Randomized Crossover Study

TypeinterventionalSponsorRush University Medical CenterRan2022 to 2022Enrolled20ConditionsHealthyArmsawake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure)
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
NCT05957588 nacompletednot on this map

Non-ventilated Prone Positioning in the COVID-19 Population

TypeinterventionalSponsorBaylor St. Luke's Medical CenterRan2021 to 2022Enrolled216ConditionsCOVID-19, Proning, Oxygenation, Length of StayArmsProning group, Control group
3 · Its place in the literature

Who cites it

210 citing papers in PubMed, 20 syntheses or guidelines pooled it, 386 citations in OpenAlex.

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150 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 7 institutions in 3 countries.

Stephan EhrmannCHRU Tours, Médecine Intensive Réanimation, CIC INSERM 1415, CRICS-TriggerSep F-CRIN research network, Tours, France; INSERM, Centre d'étude des pathologies respiratoires, U1100, Université de Tours, Tours, France.
Jie LiDepartment of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, IL, USA. Electronic address: jie_li@rush.edu.
Miguel Ibarra-EstradaUnidad de Terapia Intensiva, Hospital Civil Fray Antonio Alcalde Guadalajara, Jalisco, México.
Yonatan PerezCHRU Tours, Médecine Intensive Réanimation, CIC INSERM 1415, CRICS-TriggerSep F-CRIN research network, Tours, France.
Ivan PavlovDepartment of Emergency Medicine, Hôpital de Verdun, Montréal, QC, Canada.
Bairbre McNicholasDepartment of Anesthesia and Intensive Care Medicine, Galway University Hospitals, HRB Galway Clinical Research Facility, Galway, Ireland; School of Medicine, National University of Ireland, Galway, Ireland.
Oriol RocaServei de Medicina Intensiva, Hospital Universitari Vall d'Hebron, Barcelona, Spain; Ciber Enfermedades Respiratorias (CIberes), Instituto de Salud Carlos III, Madrid, Spain.
Sara MirzaDepartment of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, IL, USA.
David VinesDepartment of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, IL, USA.
Roxana Garcia-SalcidoUnidad de Terapia Intensiva, Hospital Civil Fray Antonio Alcalde Guadalajara, Jalisco, México.
Guadalupe Aguirre-AvalosUnidad de Terapia Intensiva, Hospital Civil Fray Antonio Alcalde Guadalajara, Jalisco, México.
Matthew W TrumpThe Iowa Clinic P.C. and Unity Point Health-Des Moines, Des Moines, IA, USA.
Mai-Anh NayMedical intensive care unit, Centre Hospitalier Régional d'Orléans, Orléans, France.
Jean DellamonicaUR2CA Unité de Recherche Clinique Université Côte d'Azur, Nice, France; Médecine Intensive Réanimation-CHU de Nice, Nice, France.
Saad NseirPôle de Médecine Intensive-Réanimation, CHU Lille, Lille, France; Inserm U1285, University of Lille, CNRS, UMR 8576, Unité de Glycobiologie Structurale et Fonctionnelle, Lille, France.
Idrees MogriPulmonary and Critical Care Medicine Division, Texas A&M School of Medicine, Baylor University Medical Center, Dallas, TX, USA.
David CosgraveDepartment of Anesthesia and Intensive Care Medicine, Galway University Hospitals, HRB Galway Clinical Research Facility, Galway, Ireland; School of Medicine, National University of Ireland, Galway, Ireland.
Dev JayaramanDivision of Critical Care, McGill University Healthcare Center Montréal, QC, Canada; Jewish General Hospital, Montréal, QC, Canada.
Joan R MasclansCritical Care Department, Hospital del Mar, IMIM (Hospital del Mar Research Institute) Barcelona, Spain; Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain.
John G LaffeyDepartment of Anesthesia and Intensive Care Medicine, Galway University Hospitals, HRB Galway Clinical Research Facility, Galway, Ireland; School of Medicine, National University of Ireland, Galway, Ireland.
Elsa TavernierClinical Investigation Center, INSERM 1415, CHRU Tours, Tours, France; Methods in Patients-Centered Outcomes and Health Research, INSERM UMR 1246, Nantes, France.
Awake Prone Positioning Meta-Trial Group
Hospital Civil de Guadalajara · MXRush University · USBaylor University Medical Center · USCentre hospitalier régional d'Orléans · FRUnityPoint Health · USClinical Investigation Center Plurithematic Tours · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAwake prone positioning has been reported to improve oxygenation for patients with COVID-19 in retrospective and observational studies, but whether it improves patient-centred outcomes is unknown. We aimed to evaluate the efficacy of awake prone positioning to prevent intubation or death in patients with severe COVID-19 in a large-scale randomised trial.

methodsIn this prospective, a priori set up and defined, collaborative meta-trial of six randomised controlled open-label superiority trials, adults who required respiratory support with high-flow nasal cannula for acute hypoxaemic respiratory failure due to COVID-19 were randomly assigned to awake prone positioning or standard care. Hospitals from six countries were involved: Canada, France, Ireland, Mexico, USA, Spain. Patients or their care providers were not masked to allocated treatment. The primary composite outcome was treatment failure, defined as the proportion of patients intubated or dying within 28 days of enrolment. The six trials are registered with ClinicalTrials.gov, NCT04325906, NCT04347941, NCT04358939, NCT04395144, NCT04391140, and NCT04477655.

findingsBetween April 2, 2020 and Jan 26, 2021, 1126 patients were enrolled and randomly assigned to awake prone positioning (n=567) or standard care (n=559). 1121 patients (excluding five who withdrew from the study) were included in the intention-to-treat analysis. Treatment failure occurred in 223 (40%) of 564 patients assigned to awake prone positioning and in 257 (46%) of 557 patients assigned to standard care (relative risk 0·86 [95% CI 0·75-0·98]). The hazard ratio (HR) for intubation was 0·75 (0·62-0·91), and the HR for mortality was 0·87 (0·68-1·11) with awake prone positioning compared with standard care within 28 days of enrolment. The incidence of prespecified adverse events was low and similar in both groups.

interpretationAwake prone positioning of patients with hypoxaemic respiratory failure due to COVID-19 reduces the incidence of treatment failure and the need for intubation without any signal of harm. These results support routine awake prone positioning of patients with COVID-19 who require support with high-flow nasal cannula.

fundingOpen AI inc, Rice Foundation, Projet Hospitalier de Recherche Clinique Interrégional, Appel d'Offre 2020, Groupement Interrégional de Recherche Clinique et d'Innovation Grand Ouest, Association pour la Promotion à Tours de la Réanimation Médicale, Fond de dotation du CHRU de Tours, Fisher & Paykel Healthcare Ltd.

Indexed as

COVID-19Patient PositioningProne PositionRespiratory InsufficiencyAdultCanadaFranceHumansIrelandMexicoProspective StudiesSARS-CoV-2SpainTreatment OutcomeUnited StatesWakefulness

Identifiers

PMID34425070
PMCPMC8378833
OpenAlexW3194098660

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

and 4 more above

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 Socratic graph.