scholarly journals Standard Care Versus Awake Prone Position in Adult Nonintubated Patients With Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Infection—A Multicenter Feasibility Randomized Controlled Trial

2021 ◽  
pp. 088506662110144
Author(s):  
Devachandran Jayakumar ◽  
Pratheema Ramachandran, DNB ◽  
Ebenezer Rabindrarajan, DNB ◽  
Bharath Kumar Tirupakuzhi Vijayaraghavan, MD ◽  
Nagarajan Ramakrishnan, AB ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Prone Position ◽  
Feasibility Study ◽  
Standard Care ◽  
Controlled Trial ◽  
Prone Positioning ◽  
Hypoxemic Respiratory Failure ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Hypoxic Respiratory Failure

Rationale: The feasibility and safety of awake prone positioning and its impact on outcomes in non-intubated patients with acute respiratory distress syndrome secondary to COVID-19 is unknown. Results of the observational studies published during this pandemic have been conflicting. In this context, we conducted a multi-center, parallel group, randomized controlled feasibility study on awake prone positioning in non-intubated patients with COVID-19 pneumonia requiring supplemental oxygen. Methods: 60 patients with acute hypoxic respiratory failure secondary to COVID-19 pneumonia requiring 4 or more liters of oxygen to maintain a saturation of ≥92% were recruited in this study. Thirty patients each were randomized to either standard care or awake prone group. Patients randomized to the prone group were encouraged to self-prone for at least 6 hours a day. The primary outcome was the proportion of patients adhering to the protocol in each group. Results: In the prone group, 43% (13 out of 30) of patients were able to self-prone for 6 or more hours a day. In the supine group, 47% (14 out of 30) were completely supine and 53% spent some hours in the prone position, but none exceeded 6 hours. There was no significant difference in any of the secondary outcomes between the 2 groups and there were no adverse events. Conclusions: Awake prone positioning in non-intubated patients with acute hypoxic respiratory failure is feasible and safe under clinical trial conditions. The results of our feasibility study will potentially help in the design of larger definitive trials to address this key knowledge gap.

scholarly journals Standard care vs. awake prone position in adult non-intubated patients with acute hypoxaemic respiratory failure secondary to COVID-19 infection – A multi-centre feasibility randomized controlled trial

2021 ◽  
Author(s):  
Devachandran Jayakumar ◽  
Pratheema Ramachandran ◽  
Ebenezer Rabindrarajan ◽  
Bharath Kumar Tirupakuzhi Vijayaraghavan ◽  
Nagarajan Ramakrishnan ◽  
...  
Keyword(s):  
Acute Respiratory Distress Syndrome ◽  
Respiratory Failure ◽  
Respiratory Distress Syndrome ◽  
Respiratory Distress ◽  
Prone Position ◽  
Standard Care ◽  
Distress Syndrome ◽  
Prone Positioning ◽  
Hypoxic Respiratory Failure ◽  
Secondary Outcomes

AbstractBackgroundThe primary manifestation of Corona Virus Disease −2019 (COVID-19) is acute hypoxic respiratory failure secondary to pneumonia and/or acute respiratory distress syndrome. Prone position has been shown to improve outcomes in ventilated patients with moderate to severe acute respiratory distress syndrome. The feasibility and safety of awake prone positioning and its impact on outcomes if any, in non-intubated patients with mild to moderate acute respiratory distress syndrome secondary to COVID-19 is unknown. Results of the observational studies published thus far in this pandemic have been conflicting. In this context, we conducted a multi-centre, parallel group, randomised controlled feasibility study on awake prone positioning in non-intubated patients with COVID-19 pneumonia requiring supplemental oxygen.Methods60 patients diagnosed with acute hypoxic respiratory failure secondary to COVID −19 pneumonia requiring 4 or more litres of oxygen to maintain a saturation of ≥ 92% were recruited in this study. Thirty patients each were randomised to either standard care or awake prone group. Patients randomised to the standard care were allowed to change their position as per comfort and patients randomized to the prone group were encouraged to self-prone for at least 6 hours a day. The primary outcome was the proportion of patients adhering to the protocol in each group. Secondary outcomes include failure of therapy leading to escalation of respiratory support, number of hours prone, maximum hours of continuous prone positioning in a day, length of stay in ICU, ICU mortality, total number of patients needing intubation and adverse events.ResultsIn the prone group, 43% (13 out of 30) of patients were able to self-prone for 6 or more hours a day. The median maximum prone duration per session was 2 hours. In the supine group, 47% (14 out of 30) were completely supine and 53% spent some hours in the prone position, but none exceeded 6 hours. There was no significant difference in any of the secondary outcomes between the two groups and there were no adverse events.InterpretationAwake proning in non-intubated patients with acute hypoxic respiratory failure is feasible and safe under clinical trial conditions. The results of our feasibility study will potentially help in the design of larger definitive trials to address this key knowledge gap.

scholarly journals Early versus late awake prone positioning in non-intubated patients with COVID-19

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Ramandeep Kaur ◽  
David L. Vines ◽  
Sara Mirza ◽  
Ahmad Elshafei ◽  
Julie A. Jackson ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Controlled Trial ◽  
Primary Objective ◽  
Intubation Rate ◽  
Prone Positioning ◽  
High Flow Nasal Cannula ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure ◽  
Randomized Controlled ◽  
Post Hoc

Abstract Background Awake prone positioning (APP) is widely used in the management of patients with coronavirus disease (COVID-19). The primary objective of this study was to compare the outcome of COVID-19 patients who received early versus late APP. Methods Post hoc analysis of data collected for a randomized controlled trial (ClinicalTrials.gov NCT04325906). Adult patients with acute hypoxemic respiratory failure secondary to COVID-19 who received APP for at least one hour were included. Early prone positioning was defined as APP initiated within 24 h of high-flow nasal cannula (HFNC) start. Primary outcomes were 28-day mortality and intubation rate. Results We included 125 patients (79 male) with a mean age of 62 years. Of them, 92 (73.6%) received early APP and 33 (26.4%) received late APP. Median time from HFNC initiation to APP was 2.25 (0.8–12.82) vs 36.35 (30.2–75.23) hours in the early and late APP group (p < 0.0001), respectively. Average APP duration was 5.07 (2.0–9.05) and 3.0 (1.09–5.64) hours per day in early and late APP group (p < 0.0001), respectively. The early APP group had lower mortality compared to the late APP group (26% vs 45%, p = 0.039), but no difference was found in intubation rate. Advanced age (OR 1.12 [95% CI 1.0–1.95], p = 0.001), intubation (OR 10.65 [95% CI 2.77–40.91], p = 0.001), longer time to initiate APP (OR 1.02 [95% CI 1.0–1.04], p = 0.047) and hydrocortisone use (OR 6.2 [95% CI 1.23–31.1], p = 0.027) were associated with increased mortality. Conclusions Early initiation (< 24 h of HFNC use) of APP in acute hypoxemic respiratory failure secondary to COVID-19 improves 28-day survival. Trial registration ClinicalTrials.gov NCT04325906.

scholarly journals Awake Prone Positioning in Patients with Hypoxemic Respiratory Failure Due to COVID-19: The PROFLO Multicenter Randomized Clinical Trial

2021 ◽  
Author(s):  
Jacob Rosen ◽  
Erik von Oelreich ◽  
Diddi Fors ◽  
Malin Jonsson Fagerlund ◽  
Knut Taxbro ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Noninvasive Ventilation ◽  
Standard Care ◽  
Controlled Trial ◽  
Group Versus ◽  
Organ Support ◽  
Control Group ◽  
Prone Positioning ◽  
Hypoxemic Respiratory Failure ◽  
Multicenter Randomized Controlled Trial

Abstract Background: The 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. Methods: We conducted a multicenter randomized controlled 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 hours 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. Results: Of 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 hours [IQR 1.8-8.4] in the control group compared with 9.0 hours 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.Conclusions: A 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 registration: ISRCTN54918435. Registered 15 June 2020 (https://doi.org/10.1186/ISRCTN54917435)

scholarly journals Noninvasive respiratory support in acute hypoxemic respiratory failure associated with COVID-19 and other viral infections

2020 ◽  
Author(s):  
Claudia Crimi ◽  
Alberto Noto ◽  
Andrea Cortegiani ◽  
Pietro Impellizzeri ◽  
Mark Elliott ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Viral Infections ◽  
Evidence Synthesis ◽  
Controlled Trial ◽  
Viral Pneumonia ◽  
Respiratory Support ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure ◽  
Randomized Controlled ◽  
Exhaled Air

ABSTRACTIntroductionNoninvasive respiratory support (NRS) such as noninvasive ventilation (NIV) and high flow nasal therapy (HFNT) have been used in the treatment of acute hypoxemic respiratory failure (AHRF) related to the coronavirus disease (COVID-19) and other viral infections. However, there is a lack of consensus in favor of or against NRS use due to the risks of worsening hypoxemia, intubation delay, and aerosols environmental contamination associated with the use of these tools. We aimed to summarize the evidence on the use of NRS in adult patients with COVID-19 and other viral pneumonia (i.e. H1N1, SARS, MERS) and AHRF. We also searched for studies evaluating the risk of aerosolization/contamination with these tools.Evidence AcquisitionWe searched MEDLINE, PubMed EMBASE and two major preprint servers (biorXiv and medRxiv) from inception to April 14, 2020, for studies on the use of respiratory support in AHRF and viral pneumonia.Evidence SynthesisThe search identified 4086 records and we found only one randomized controlled trial out of 58 studies included, with great variabilities in support utilization and failure rates. Fifteen studies explored the issue of aerosolization/contamination showing a high risk of airborne transmission via droplets generation during the use of these modalitiesConclusionsUse of NRS and treatment failure in the context of COVID-19 and viral infection associated-AHRF, varied widely. Dispersion of exhaled air is different depending on the type of respiratory therapies and interfaces. Data from randomized controlled trials are lacking.

scholarly journals AYUSH-64 as an adjunct to Standard Care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India

2021 ◽  
Author(s):  
Harbans Singh ◽  
Sumit Shrivastva ◽  
Babita Yadav ◽  
Amit Kumar Rai ◽  
Sophia Jameela ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Inflammatory Markers ◽  
Standard Care ◽  
Controlled Trial ◽  
Control Group ◽  
Rt Pcr ◽  
Open Label ◽  
Clinical Recovery ◽  
Randomized Controlled ◽  
Significant Difference

Background: There is limited evidence on the safety and efficacy of administering Ayurveda interventions as add-on to the standard care for COVID-19. Objective: To explore the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in the management of mild to moderate stage COVID-19.Design, setting, participants and interventions: This was an open-label randomized controlled trial with 80 patients of mild to moderate stage COVID-19. Participants in the AYUSH-64 add-on group received two tablets (500 mg each) three times daily for 30 days along with conventional standard care (Paracetamol, Cetirizine, Vitamin C, and Azithromycin). The control group received standard care alone. Main outcome measures: The primary outcome assessed was the proportion of participants with clinical recovery and negative RT-PCR assay for COVID-19 on day 7, 15, 23, and 30. Additionally, change in pro-inflammatory markers, metabolic functions, HRCT chest and incidence of Adverse Drug Reaction (ADR) / Serious Adverse Event (SAE) were assessed.Results: Statistically significant difference was observed in the proportion of participants with clinical recovery in the AYUSH-64 add-on group (p&lt;0.001) at each of the scheduled follow-up visits. All the participants in the AYUSH-64 add-on group clinically recovered by day 23 compared to 32.4 per cent in the control group. The mean duration for clinical recovery in AYUSH-64 add-on group (5.8 ± 2.67 days) was less as compared to control group (10.0 ± 4.06 days). The proportion of participants who turned RT-PCR negative for COVID-19 on day 7, 15, and 23 were 81.8, 94.5, and 100 per cent in AYUSH-64 add-on group, and 79.4, 94.5, and 97.2 per cent in control group, however, the difference observed was statistically not significant (p=0.314). The proportion of participants with improvement in HRCT chest was statistically significant in AYUSH-64 add-on group (p=0.031) unlike in control group (p=0.210). Similar reductions in most inflammatory markers measured (IL-6, CRP, Serum ferritin, and LDH) on day 30 (p&lt;0.05) were observed in both groups. Conclusion: AYUSH-64 as adjunct to standard conventional care is safe and hastens clinical recovery in adult patients with mild to moderate COVID-19.

scholarly journals Awake prone positioning in non-intubated patients with acute hypoxemic respiratory failure due to COVID-19: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Ivan Pavlov ◽  
Hangyong He ◽  
Bairbre McNicholas ◽  
Yonatan Perez ◽  
Elsa Tavernier ◽  
...  
Keyword(s):  
Systematic Review ◽  
Respiratory Failure ◽  
Observational Studies ◽  
Meta Analysis ◽  
Current Evidence ◽  
Intubation Rate ◽  
Prone Positioning ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure ◽  
Randomized Controlled

Abstract Background: Awake prone positioning (APP) has been advocated to improve oxygenation and prevent intubations of patients with acute hypoxemic respiratory failure due to coronavirus disease 2019 (COVID-19). This paper aims to synthesize the available evidence on the efficacy of APP.Methods: We performed a systematic review and meta-analysis of observational studies to compare oxygenation parameters in-hospital intubation rate in patients treated with APP or with standard care.Results: A total of 46 published and 4 unpublished observational studies that included 2994 patients were included. APP was associated with significant improvement of various oxygenation parameters in 19 studies (n=381) that reported this outcome. The intubation rate was 27% (95%CI, 19 to 37%) in the 870 patients treated with APP, as compared to 30% (95%CI, 20 to 42%) in the 852 patients treated with usual care (p=0.71).Conclusions: On the basis of the available evidence, it is not possible to demonstrate efficacy of APP for patients with COVID-19 acute respiratory failure, as assessed by the need for invasive ventilation. Routine implementation of APP outside of a clinical trial is not supported by current evidence. Randomized controlled clinical studies are urgently needed to definitively assess the utility of APP in these patients.Registered on PROSPERO on August 3d, 2020, CRD42020201947.

Awake Prone Positioning in Nonintubated Spontaneous Breathing ICU Patients with Acute Hypoxemic Respiratory Failure (PRONELIFE) – Protocol for a Randomized Clinical Trial

2021 ◽  
Author(s):  
Luis Morales-Quinteros ◽  
Marcus J Schultz ◽  
Ary Serpa Neto ◽  
Massimo Antonelli ◽  
Domenico L Grieco ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Respiratory Failure ◽  
Tracheal Intubation ◽  
Standard Care ◽  
Total Duration ◽  
Prone Positioning ◽  
Invasive Ventilation ◽  
Hypoxemic Respiratory Failure ◽  
Acute Hypoxemic Respiratory Failure ◽  
Icu Patients

Abstract BackgroundIt is uncertain whether awake prone positioning can prevent intubation for invasive ventilation in spontaneous breathing critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation related complications.Design and MethodsThe PRONELIFE study is an investigator–initiated, international, multicenter, randomized clinical trial in patients who may need invasive ventilation because of acute hypoxemic respiratory failure. Consecutive patients admitted to participating ICUs are randomly assigned to standard care with awake prone positioning, versus standard care without awake prone positioning. The primary endpoint is a composite of tracheal intubation and all–cause mortality in the first 14 days after enrolment. Secondary endpoints include time to tracheal intubation and effects of awake prone positioning on oxygenation parameters, dyspnea sensation, and complications. Other endpoints are the number of days free from ventilation and alive at 28 days, total duration of use of noninvasive respiratory support, total duration of invasive ventilation, length of stay in ICU and hospital, and mortality in ICU and hospital, and at 28, 60, and 90 days. We will also collect data regarding the tolerance of prone positioning.DiscussionThe PRONELIFE study is amongst the first randomized clinical trials investigating the effect of awake prone positioning on intubation rate in ICU patients with acute hypoxemic failure from any cause. The PRONELIFE study is sufficiently sized to determine the effect of awake prone positioning on intubation for invasive ventilation––patients are eligible in case of acute hypoxemic respiratory failure without restrictions regarding etiology. The PRONELIFE study is a pragmatic trial in which blinding is impossible––however, as around 35 ICUs worldwide will participate in this study, its findings will be highly generalizable. The findings of the PRONELIFE study has the potential to change clinical management of patients who may need invasive ventilation because of acute hypoxemic respiratory failure.Trial registrationISRCTN, ISRCTN11536318. Registered 17 September 2021, https://www.isrctn.com/ISRCTN11536318The PRONELIFE study is registered at clinicaltrials.gov with reference number NCT04142736 (October, 2019).

Sign in / Sign up

Export Citation Format

Share Document