Project description:Background Infection with SARS-CoV-2 can result in Coronavirus Disease–19 (COVID-19) [1, 2]. While the majority of patients are asymptomatic or have mild disease [3], approximately 14% develop more severe disease including hypoxemic respiratory failure and/or Acute Respiratory Distress Syndrome (ARDS) [3]. Prone positioning is a life-saving intervention for mechanically ventilated patients with moderate-severe ARDS [4]. Based on this, the World Health Organization (WHO) guidelines recommend these patients be considered for a trial of prone positioning [5]. Recently the use of prone positioning in awake non-intubated COVID-19 patients has been recommended by several notable organizations with the goal of preventing intubation and potentially improving patient-oriented outcomes [6, 7]. In contrast to prone positioning for intubated mechanically ventilated patients with ARDS, there have been no randomized control trials examining the role of awake prone positioning for non-intubated patients with hypoxemic respiratory failure. To further explore this question we used rapid review methodology (Tricco et al., 2015 [8]) to quickly identify and synthesize studies examining the effect of awake prone positioning on patients with hypoxemic respiratory failure (including those with ARDS and/or COVID-19). Methods We have elected to use “rapid review” methodology rather than “systematic review” methodology primarily due to the speed and efficiency through which we are able to conduct this review, as previously described [8]. In the absence of an EQUATOR guidance document, we used PRISMA guidelines where applicable [9]. Studies were included if they met the following criteria 1) population – non-intubated patients with hypoxemic respiratory failure, 2) intervention – prone positioning, 3) comparator – usual management, 4) outcomes – intubation, survival, change in respiratory parameters, adverse events, 5) setting – hospitalized patients 6) study design – observational or randomized control trial. Studies were not limited to ARDS or COVID-19 patients. The search strategy was developed by a critical care physician (KP), a critical care epidemiologist (KF) and a medical librarian (NL) (See search details in Online Supplement). Briefly, the search strategy involved combinations of keywords and subject headings relating to the concepts of, 1) SARS-Cov-2 or COVID-19 or coronavirus, 2) awake prone positioning, and 3) hypoxemic respiratory failure, including but not limited to ARDS and other potentially relevant conditions. The search was conducted on May 19, 2020 and was updated on August 7, 2020 with no restrictions on publication language or date. Databases and grey literature sources searched included: MEDLINE (Ovid), PubMed, Trip PRO, Cochrane Library, LitCOVID, WHO COVID-19 Research Database, Centre for Evidence-Based Medicine (CEBM), National Institute for Health and Care Excellence (NICE), medRxiv, BMJ Best Practice, Cambridge Coronavirus Free Access Collection, and Google Scholar. Titles and abstracts were reviewed independently and in duplicate (KP and JW) for selection for full text review. Disagreements were resolved through discussion or with a third reviewer (KS). Full text review and data abstraction was conducted independently and in duplicate (KP, KS, JW). Data abstracted included study characteristics, participant demographics, and outcomes.
Project description:Prone positioning reduces mortality in the management of intubated patients with moderate-to-severe acute respiratory distress syndrome. It allows improvement in oxygenation by improving ventilation/perfusion ratio mismatching.Because of its positive physiological effects, prone positioning has also been tested in non-intubated, spontaneously breathing patients, or "awake" prone positioning. This review provides an update on awake prone positioning for hypoxaemic respiratory failure, in both coronavirus disease 2019 (COVID-19) and non-COVID-19 patients. In non-COVID-19 acute respiratory failure, studies are limited to a few small nonrandomised studies and involved patients with different diseases. However, results have been appealing with regard to oxygenation improvement, especially when combined with noninvasive ventilation or high-flow nasal cannula.The recent COVID-19 pandemic has led to a major increase in hospitalisations for acute respiratory failure. Awake prone positioning has been used with the aim to prevent intensive care unit admission and mechanical ventilation. Prone positioning in conscious, non-intubated COVID-19 patients is used in emergency departments, medical wards and intensive care units.Several trials reported an improvement in oxygenation and respiratory rate during prone positioning, but impacts on clinical outcomes, particularly on intubation rates and survival, remain unclear. Tolerance of prolonged prone positioning is an issue. Larger controlled, randomised studies are underway to provide results concerning clinical benefit and define optimised prone positioning regimens.
Project description:PurposeProne positioning of non-intubated patients with coronavirus disease (COVID-19) and hypoxemic respiratory failure may prevent intubation and improve outcomes. Nevertheless, there are limited data on its feasibility, safety, and physiologic effects. The objective of our study was to assess the tolerability and safety of awake prone positioning in COVID-19 patients with hypoxemic respiratory failure.MethodsThis historical cohort study was performed across four hospitals in Calgary, Canada. Included patients had suspected COVID-19 and hypoxic respiratory failure requiring intensive care unit (ICU) consultation, and underwent awake prone positioning. The duration, frequency, tolerability, and adverse events from prone positioning were recorded. Respiratory parameters were assessed before, during, and after prone positioning. The primary outcome was the tolerability and safety of prone positioning.ResultsSeventeen patients (n = 12 ICU, n = 5 hospital ward) were included between April and May 2020. The median (range) number of prone positioning days was 1 (1-7) and the median number of sessions was 2 (1-6) per day. The duration of prone positioning was 75 (30-480) min, and the peripheral oxygen saturation was 91% (84-95) supine and 98% (92-100) prone. Limitations to prone position duration were pain/general discomfort (47%) and delirium (6%); 47% of patients had no limitations. Seven patients (41%) required intubation and two patients (12%) died.ConclusionsIn a small sample, prone positioning non-intubated COVID-19 patients with severe hypoxemia was safe; however, many patients did not tolerate prolonged durations. Although patients had improved oxygenation and respiratory rate in the prone position, many still required intubation. Future studies are required to determine methods to improve the tolerability of awake prone positioning and whether there is an impact on clinical outcomes.
Project description:Introduction In March and April 2020 of the COVID-19 pandemic, site clinical practice guidelines were implemented for prone positioning of awake, alert, spontaneously breathing suspected COVID-19 patients in hypoxic respiratory distress. The purpose of this pandemic disaster practice improvement project was to measure changes in pulse oximetry associated with prone positioning on awake, alert, spontaneously breathing non-intubated adult acute respiratory distress, or ARDS, patients with COVID-19 infection. Methods A retrospective chart review of ED COVID-19 positive patients from 3/30/2020 to 4/30/2020 was conducted for patients with a room air pulse oximetry < 90% and a pre-prone position pulse oximetry ? 94% who tolerated prone positioning for at least 30 minutes. The primary outcome was change in pulse oximetry associated with prone positioning, measured on room air, with supplemental oxygen, and approximately 30 minutes after initiating prone positioning. Median differences were compared with the Wilcoxon signed-rank test. Results Of the 440 COVID-19 patients, 31 met inclusion criteria. Median pulse oximetry increased as 83% (IQR= 75%-86%) on room air, 90% (IQR=89%-93%) with supplemental oxygen, and 96% (IQR=94%-98%) with prone positioning (x.xx, p<.001). 45% (N=14) were intubated during their hospital stay and 26% (N=8) of the included patients died. Conclusion In awake, alert, and spontaneously breathing patients with COVID-19, an initially low pulse oximetry reading improved with prone positioning. Future studies are needed to determine the association of prone positioning with subsequent endotracheal intubation and mortality.
Project description:BackgroundThe effect of awake prone positioning on intubation rates is not established. The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19.MethodsWe conducted a multicenter randomized clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO2/FiO2 ratio ≤ 20 kPa were randomly assigned to a protocol targeting 16 h prone positioning per day or standard care. The primary endpoint was intubation within 30 days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator-free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility.ResultsOf 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30 days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46-2.21), P = 0.99). Median prone duration was 3.4 h [IQR 1.8-8.4] in the control group compared with 9.0 h per day [IQR 4.4-10.6] in the prone group (P = 0.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference - 18% (95% CI - 2 to - 33%); P = 0.032). There were no other differences in secondary outcomes between groups.ConclusionsThe implemented protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care.Trial registrationISRCTN54917435. Registered 15 June 2020 ( https://doi.org/10.1186/ISRCTN54917435 ).
Project description:ObjectivesTherapies for patients with respiratory failure from coronavirus disease 2019 are urgently needed. Early implementation of prone positioning ventilation improves survival in patients with acute respiratory distress syndrome, but studies examining the effect of proning on survival in patients with coronavirus disease 2019 are lacking. Our objective was to estimate the effect of early proning initiation on survival in patients with coronavirus disease 2019-associated respiratory failure.DesignData were derived from the Study of the Treatment and Outcomes in Critically Ill Patients with coronavirus disease 2019, a multicenter cohort study of critically ill adults with coronavirus disease 2019 admitted to 68 U.S. hospitals. Using these data, we emulated a target trial of prone positioning ventilation by categorizing mechanically ventilated hypoxemic (ratio of Pao2 over the corresponding Fio2 ≤ 200 mm Hg) patients as having been initiated on proning or not within 2 days of ICU admission. We fit an inverse probability-weighted Cox model to estimate the mortality hazard ratio for early proning versus no early proning. Patients were followed until death, hospital discharge, or end of follow-up.SettingICUs at 68 U.S. sites.PatientsCritically ill adults with laboratory-confirmed coronavirus disease 2019 receiving invasive mechanical ventilation with ratio of Pao2 over the corresponding Fio2 less than or equal to 200 mm Hg.InterventionsNone.Measurements and main resultsAmong 2,338 eligible patients, 702 (30.0%) were proned within the first 2 days of ICU admission. After inverse probability weighting, baseline and severity of illness characteristics were well-balanced between groups. A total of 1,017 (43.5%) of the 2,338 patients were discharged alive, 1,101 (47.1%) died, and 220 (9.4%) were still hospitalized at last follow-up. Patients proned within the first 2 days of ICU admission had a lower adjusted risk of death compared with nonproned patients (hazard ratio, 0.84; 95% CI, 0.73-0.97).ConclusionsIn-hospital mortality was lower in mechanically ventilated hypoxemic patients with coronavirus disease 2019 treated with early proning compared with patients whose treatment did not include early proning.
Project description:Prone position has been used in acute respiratory distress syndrome (ARDS) patients for more than 40 years in ICU. After having demonstrated its capability to significantly improve oxygenation in a large number of patients, sometimes dramatically, this procedure has been found to prevent ventilator-induced lung injury, the primary concern for the intensivists managing ARDS patients. Over the time, several trials have been done, which regularly improved and refined from each other. At the end, significant improvement in survival has been demonstrated in the most severe ARDS patients, at a threshold of 100-150 mmHg PaO2/FiO2 ratio. The effect of proning on survival cannot be predicted and seems unrelated with both severity of oxygenation impairment and oxygenation response to proning. The rate of complication is declining with the increase in centers expertise. The pressure sores are more frequent in prone and require a special attention. Prone position is a key component of lung protective mechanical ventilation and should be used as a first line therapy in association with low tidal volume and neuromuscular blocking agents in patients with severe ARDS.
Project description: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.