scholarly journals Protocolized Post-Extubation Respiratory Support to prevent reintubation: protocol and statistical analysis plan for a clinical trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030476 ◽  
Author(s):  
Jonathan Dale Casey ◽  
Erin R Vaughan ◽  
Bradley D Lloyd ◽  
Peter A Bilas ◽  
Eric J Hall ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Usual Care ◽  
Invasive Mechanical Ventilation ◽  
High Flow ◽  
Respiratory Support ◽  
Invasive Ventilation ◽  
High Flow Nasal Cannula ◽  
Non Invasive ◽  
Non Invasive Ventilation ◽  
Risk Patients

IntroductionFollowing extubation from invasive mechanical ventilation, nearly one in seven critically ill adults requires reintubation. Reintubation is independently associated with increased mortality. Postextubation respiratory support (non-invasive ventilation or high-flow nasal cannula applied at the time of extubation) has been reported in small-to-moderate-sized trials to reduce reintubation rates among hypercapnic patients, high-risk patients without hypercapnia and low-risk patients without hypercapnia. It is unknown whether protocolised provision of postextubation respiratory support to every patient undergoing extubation would reduce the overall reintubation rate, compared with usual care.Methods and analysisThe Protocolized Post-Extubation Respiratory Support (PROPER) trial is a pragmatic, cluster cross-over trial being conducted between 1 October 2017 and 31 March 2019 in the medical intensive care unit of Vanderbilt University Medical Center. PROPER compares usual care versus protocolized post-extubation respiratory support (a respiratory therapist-driven protocol that advises the provision of non-invasive ventilation or high-flow nasal cannula based on patient characteristics). For the duration of the trial, the unit is divided into two clusters. One cluster receives protocolised support and the other receives usual care. Each cluster crosses over between treatment group assignments every 3 months. All adults undergoing extubation from invasive mechanical ventilation are enrolled except those who received less than 12 hours of mechanical ventilation, have ‘Do Not Intubate’ orders, or have been previously reintubated during the hospitalisation. The anticipated enrolment is approximately 630 patients. The primary outcome is reintubation within 96 hours of extubation.Ethics and disseminationThe trial was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.Trial registration numberNCT03288311.

scholarly journals High Flow Nasal Cannula Oxygenation

JMS SKIMS ◽  
2020 ◽  
Vol 23 (3) ◽  
Author(s):  
Tajamul Hussain Shah ◽  
Suhail Mantoo ◽  
Rafi Ahmad Jan
Keyword(s):  
Face Mask ◽  
High Flow ◽  
Nasal Cannula ◽  
Respiratory Support ◽  
Low Flow ◽  
Invasive Ventilation ◽  
High Flow Nasal Cannula ◽  
Non Invasive ◽  
Non Invasive Ventilation ◽  
Flow Devices

High Flow Nasal Cannula Oxygenation The current pandemic of COVID-19 caused by novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tested the healthcare infrastructure throughout the globe at all possible levels. Early reports suggest about 20% of patients infected with SARS-CoV-2 require hospitalization and 5-8% require admission to intensive care unit (ICU) due to severe disease.Supplementation of oxygen provided by various conventional oxygen therapy (COT) devices (like nasal prongs, face mask, venture mask or non-rebreather mask) may not be sufficient in cases of worsening respiratory failure. One form of escalating respiratory support in such patients is a high flow nasal oxygenation device. High flow nasal cannula oxygenation (HFNC) is a form of non invasive respiratory support. It acts as a bridge between low flow devices and non invasive ventilation and may reduce the need for intubation.

scholarly journals Limitations of the ARDS criteria during high-flow oxygen or non-invasive ventilation: Evidence from critically ill COVID-19 patients

2021 ◽  
Author(s):  
Michael Hultström ◽  
Ola Hellkvist ◽  
Lucian Covaciu ◽  
Filip Fredén ◽  
Robert Frithiof ◽  
...  
Keyword(s):  
Invasive Mechanical Ventilation ◽  
High Flow ◽  
University Hospital ◽  
Respiratory Support ◽  
Arterial Oxygen ◽  
Invasive Ventilation ◽  
Steady State Condition ◽  
Non Invasive ◽  
Non Invasive Ventilation ◽  
High Flow Oxygen

Abstract Introduction The ratio of partial pressure of arterial oxygen to inspired oxygen fraction (PaO2/FIO2) during invasive mechanical ventilation (MV) is used as criteria to grade the severity of respiratory failure in acute respiratory distress syndrome (ARDS). During the SARS-CoV2 pandemic the use of PaO2/FIO2 ratio has been increasingly used in non-invasive respiratory support such as high-flow nasal cannula (HFNC) and non-invasive ventilation (NIV). The grading of hypoxemia in non-invasively ventilated patients is uncertain. The main hypothesis, investigated in this study, was that the PaO2/FIO2 ratio does not change when switching between MV, NIV and HFNC. Methods This was a sub-study of a single-center prospective observational study of patients admitted to the intensive care unit (ICU) at Uppsala University Hospital in Sweden for critical COVID-19. In a steady state condition, the PaO2/FIO2 ratio was recorded before and after any change between two of the studied respiratory support techniques (i.e., HFNC, NIV and MV). Results A total of 148 patients were included in the present analysis. We find that any change in respiratory support from or to HFNC caused a significant change in PaO2/FIO2 ratio (up to 48 mmHg, from HFNC to MV). Changes in respiratory support between NIV and MV did not show consistent change in PaO2/FIO2 ratio. In patients classified as mild to moderate ARDS during MV, the change from HFNC to MV showed a variable increase in PaO2/FIO2 ratio ranging between 52 and 140 mmHg (median of 127 mm Hg). This made prediction of ARDS severity during MV from the apparent ARDS grade during HFNC impossible. Conclusion HFNC is associated with lower PaO2/FIO2 ratio than either NIV or MV in the same patient, while NIV and MV provided similar PaO2/FIO2 and thus ARDS grade by Berlin definition. The large variation of PaO2/FIO2 ratio precludes using ARDS grade as a measure of pulmonary damage during HFNC.

scholarly journals ENVIRONMENTAL SAFETY EVALUATION OF THE PROTECTION AND ISOLATION SYSTEM FOR PATIENTS WITH COVID-19.

2020 ◽  
Author(s):  
Claudio Almeida Quadros ◽  
Maria Carolina BDM Leal ◽  
Carlos A Baptista-Sobrinho ◽  
Carolina KV Nonaka ◽  
Bruno SF Souza ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Healthcare Professionals ◽  
High Flow ◽  
Invasive Ventilation ◽  
High Flow Nasal Cannula ◽  
Rt Pcr ◽  
Isolation System ◽  
Non Invasive ◽  
Non Invasive Ventilation ◽  
And Biological Markers

Background SARS-CoV-2 has high transmissibility through respiratory droplets and aerosol, making COVID-19 a worldwide pandemic. In its severe form, patients progress to respiratory failure. Non-invasive mechanical ventilation restrictions and early orotracheal intubation have collapsed health systems due to insufficient intensive care unit beds and mechanical ventilators. COVID-19 dedicated healthcare professionals have high infection rates. This publication describes experimental testing of the Protection and Isolation System for Patients with COVID-19 (PISP/COVID-19). Method PISP/COVID-19 is a disposable transparent polyethylene plastic that covers the patient's entire hospital bed, with its internal air aspirated by the hospital's vacuum system attached to a microparticle filter. Experiments validated PISP/COVID-19's ability to block aerosolized microparticles dissemination. Caffeine was used as a molecular marker, with leakage evaluation through sensors analysis using nuclear magnetic resonance spectroscopy. The biological marker was synthetic SARS-CoV-2 RNA, using Reverse Transcription Polymerase Chain Reaction (RT-PCR) as the detection method. Results PISP/COVID-19 was effective against molecular and biological markers environmental dispersion in simulations of non-invasive ventilation, high-flow nasal cannula oxygen and mechanical ventilation isolation. Caffeine was not detected in any of the sensors positioned at points outside the PISP/COVID-19. The ability of PISP/COVID-19 to retain virus particles and protect the surrounding environment was confirmed by detection and gradients quantification of synthetic SARS-CoV-2 RNA by RT-PCR. Conclusion PISP/COVID-19 was effective in the retention of the molecular and biological markers in all tested simulations. Considering the current pandemic, PISP/COVID-19 might increase the use of non-invasive ventilation, high-flow nasal cannula oxygen and provide additional protection to healthcare professionals.

Incidence, predictors and prognosis of respiratory support in non-ST segment elevation myocardial infarction

2020 ◽  
pp. 204887262091994
Author(s):  
Thomas Metkus ◽  
P Elliott Miller ◽  
Carlos L Alviar ◽  
Jacob C Jentzer ◽  
Sean van Diepen ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Mechanical Ventilation ◽  
Invasive Mechanical Ventilation ◽  
Respiratory Support ◽  
Invasive Ventilation ◽  
St Segment Elevation ◽  
Non Invasive ◽  
Segment Elevation Myocardial Infarction ◽  
Non Invasive Ventilation ◽  
St Segment

Background The incidences of invasive mechanical ventilation and non-invasive ventilation among patients with non-ST segment elevation myocardial infarction and associated prognosis are not well characterized. Methods We conducted a retrospective cohort study of patients with admission diagnosis of non-ST segment elevation myocardial infarction using the US National Inpatient Sample database between 2002–2014. The exposure variable was invasive mechanical ventilation or non-invasive ventilation within 24 h of admission, compared to no respiratory support. The primary outcome was in-hospital mortality. We determined the association between respiratory support and mortality using Cox proportional hazard models. Results A total of 4,152,421 non-ST segment elevation myocardial infarction hospitalizations were identified, among whom 1.3% required non-invasive ventilation and 1.9% required invasive mechanical ventilation. Non-invasive ventilation use increased over time (0.4% in 2002 to 2.4% in 2014, p<0.001) while there was no definite trend in invasive mechanical ventilation use. Revascularization was lower for non-ST segment elevation myocardial infarction hospitalizations including invasive mechanical ventilation (23.9%) and non-invasive ventilation (14.5%) compared to 36.5% of those without respiratory support ( p<0.001). In-hospital mortality was 3.1% for non-ST segment elevation myocardial infarction without respiratory support compared to 9.2% with non-invasive ventilation (adjusted hazard ratio 1.86, 95% confidence interval 1.74–1.98) and 37.2% with invasive mechanical ventilation (adjusted hazard ratio 3.03, 95% confidence interval 2.88–3.19). Mortality for non-ST segment elevation myocardial infarction-non-invasive ventilation is improving over time while mortality for non-ST segment elevation myocardial infarction-invasive mechanical ventilation is increasing over time. Conclusion Mechanical respiratory support in non-ST segment elevation myocardial infarction is used in an important minority of cases, is increasing and is independently associated with mortality. Studies of the optimal management of acute coronary syndrome complicated by respiratory failure are needed to improve outcomes.

scholarly journals Hydroxychloroquine alone or in combination with azithromycin to prevent major clinical events in hospitalised patients with coronavirus infection (COVID-19): rationale and design of a randomised, controlled clinical trial

2020 ◽  
Author(s):  
Alexandre B Cavalcanti ◽  
Fernando G Zampieri ◽  
Luciani CP Azevedo ◽  
Regis G Rosa ◽  
Alvaro Avezum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
High Flow ◽  
Ordinal Scale ◽  
Invasive Ventilation ◽  
High Flow Nasal Cannula ◽  
Supplementary Oxygen ◽  
Non Invasive ◽  
Non Invasive Ventilation ◽  
Hospitalised Patients

Introduction: Hydroxychloroquine and its combination with azithromycin have been suggested to improve viral clearance in patients with COVID-19, but its effect on clinical outcomes remains uncertain. Methods and analysis: We describe the rationale and design of an open-label pragmatic multicentre randomised (concealed) clinical trial of 7 days of hydroxychloroquine (400 mg BID) plus azithromycin (500 mg once daily), hydroxychloroquine 400 mg BID, or standard of care for moderately severe hospitalised patients with suspected or confirmed COVID-19 (in-patients with up to 4L/minute oxygen supply through nasal catheter). Patients are randomised in around 50 recruiting sites and we plan to enrol 630 patients with COVID-19. The primary endpoint is a 7-level ordinal scale measured at 15-days: 1)not hospitalised, without limitations on activities; 2)not hospitalised, with limitations on activities; 3)hospitalised, not using supplementary oxygen; 4)hospitalised, using supplementary oxygen; 5)hospitalised, using high-flow nasal cannula or non-invasive ventilation; 6)hospitalised, on mechanical ventilation; 7)death. Secondary endpoints are the ordinal scale at 7 days, need for mechanical ventilation and rescue therapies during 15 days, need of high-flow nasal cannula or non-invasive ventilation during 15 days, length of hospital stay, in-hospital mortality, thromboembolic events, occurrence of acute kidney injury, and number of days free of respiratory support at 15 days. Secondary safety outcomes include prolongation of QT interval on electrocardiogram, ventricular arrhythmias, and liver toxicity. The main analysis will consider all patients with confirmed COVID-19 in the groups they were randomly assigned. Ethics and dissemination: This study has been approved by Brazil's National Ethic Committee (CONEP) and National Health Surveillance Agency (ANVISA). An independent data monitoring committee will perform interim analyses and evaluate adverse events throughout the trial. Results will be submitted for publication after enrolment and follow-up are complete, as well as presented and reported to local health agencies. ClinicalTrials.gov identifier: NCT04322123

scholarly journals Tocilizumab in COVID-19 – A Bayesian reanalysis of RECOVERY

2021 ◽  
Author(s):  
Arthur M. Albuquerque ◽  
Lucas Tramujas ◽  
Lorenzo R. Sewanan ◽  
James M. Brophy
Keyword(s):  
Mechanical Ventilation ◽  
Usual Care ◽  
Hospital Discharge ◽  
Bayesian Methods ◽  
Invasive Mechanical Ventilation ◽  
Sensitivity Analyses ◽  
Invasive Ventilation ◽  
Posterior Probabilities ◽  
Non Invasive ◽  
Non Invasive Ventilation

Background: Randomised Evaluation of COVID-19 Therapy (RECOVERY) demonstrated that tocilizumab reduces mortality in hospitalized COVID-19 patients. However, substantial uncertainty remains whether tocilizumab's effect is similar across clinically relevant subgroups. Whether this uncertainty can be resolved with Bayesian methods is unknown. Design, Setting, Participants, and Interventions: RECOVERY was a controlled, open-label, platform UK trial that randomized (1:1) 4116 adults with oxygen saturation <92% on room air or receiving oxygen therapy with C-reactive protein ≥75 mg/L to either usual care or tocilizumab plus usual care. Main outcome measures: Mortality and hospital discharge within 28 days. Methods: Using Bayesian methods, we combined RECOVERY with evidence-based priors incorporating previous COVID-19 tocilizumab RCTs. The probability of tocilizumab's benefit for respiratory support and corticosteroid subgroups and sensitivity analyses were performed with different prior distributions and baseline risks. Results: For all-cause mortality, the posterior probabilities of decreased deaths with tocilizumab were >99% and 19% in patients using and not using corticosteroids, respectively. In patients on simple oxygen only, non-invasive ventilation and invasive mechanical ventilation, the probabilities of decreased mortality were 96%, >99% and 77%, respectively. The probabilities for a clinically significant mortality reduction, as assessed by an absolute risk difference > 3% (number needed to treat ≤ 33), were 77%, 96%, 56%, respectively. Sensitivity analyses highlighted the uncertainty and lack of conclusive evidence for tocilizumab's effect in patients on invasive mechanical ventilation and those without concurrent corticosteroids. Posterior probabilities of benefit for hospital discharge outcome were high and consistent across most subgroups. Conclusions: In this Bayesian reanalysis, COVID-19 hospitalized patients exposed to corticosteroids or on non-invasive ventilation have a high probability of a clinically meaningful mortality benefit from tocilizumab. Tocilizumab also likely improves discharge from hospital in most subgroups. Future research should further address if patients on invasive mechanical ventilation can also benefit from tocilizumab.

Failure of High Flow Nasal Cannula and Subsequent Intubation Is Associated With Increased Mortality as Compared to Failure of Non-Invasive Ventilation and Mechanical Ventilation Alone: A Real-World Retrospective Analysis

2020 ◽  
pp. 088506662096804
Author(s):  
David C. Miller ◽  
Jie Pu ◽  
David Kukafka ◽  
Christian Bime
Keyword(s):  
Mechanical Ventilation ◽  
Respiratory Failure ◽  
Retrospective Analysis ◽  
Real World ◽  
High Flow ◽  
Nasal Cannula ◽  
Invasive Ventilation ◽  
High Flow Nasal Cannula ◽  
Non Invasive ◽  
Non Invasive Ventilation

Background: Despite the increasing use of high flow nasal cannula oxygenation systems (HFNC) in clinical practice, little is known about its role in all cause respiratory failure as compared to traditional non-invasive ventilation (BiPAP). Furthermore, the effect of HFNC on mortality is unknown. Methods: We conducted a retrospective analysis of 49,853 patients with respiratory failure treated with non-invasive respiratory support (HFNC or BiPAP) and/or invasive mechanical ventilation (IMV) between 2017 and 2018. Results: Patients initially treated with HFNC who underwent subsequent intubation and IMV had a higher mortality rate as compared to patients who were initially treated with BiPAP and underwent subsequent intubation and IMV (34.8% vs 26.3%, p < 0.0001, OR 1.49, 95% CI 1.26,1.76). Patients first treated with HFNC who underwent subsequent intubation and IMV had a significantly increased mortality compared to patients who underwent immediate intubation and IMV (34.8% vs. 21.5%, p ≤ 0.0001, OR 1.94, 95% CI 1.67, 2.27). Stratified based on ICD-10 diagnosis, patients with a diagnosis of COPD exacerbation or heart failure treated with HFNC and subsequent intubation and IMV had higher mortality as compared to those treated with immediate IMV alone. This trend did not hold true for patients with a diagnosis of pneumonia. Conclusion: In a real-world retrospective analysis, use of HFNC was associated with increased mortality as compared to BiPAP and IMV alone. Further study is needed to confirm these associations.

scholarly journals High Flow Nasal Canula (HFNC) In COVID-19 Associated Acute Respiratory Distress Syndrome (CARDS)

2021 ◽  
Vol 6 (2) ◽  
pp. 83-95
Author(s):  
Faisal Salahuddin Sommeng ◽  
Syafri Kamsul Arif ◽  
Hisbullah Hisbullah ◽  
Muhammad Rum
Keyword(s):  
Mechanical Ventilation ◽  
Acute Respiratory Distress Syndrome ◽  
Respiratory Distress Syndrome ◽  
Respiratory Distress ◽  
Distress Syndrome ◽  
Invasive Mechanical Ventilation ◽  
High Flow ◽  
Invasive Ventilation ◽  
Non Invasive ◽  
Non Invasive Ventilation

Pasien COVID-19 related Acute Respiratory Distress Syndrome (CARDS) dengan gejala ARDS sedang hingga berat memerlukan Invasive mechanical ventilation (IMV) dan memiliki prognosis yang buruk dengan angka ARDS sekitar 75% serta 63% menerima Invasive mechanical ventilation (IMV) dengan tingkat kematian 59% . Tingginya angka kematian pasien CARDS mendapat terapi invasive mechanical ventilation (IMV) menyebabkan para praktisi kesehatan berusaha untuk menunda intubasi dan ventilasi mekanik secara dini sehingga Non Invasive Ventilation Mechanic (NIV), CPAP dan HFNC menjadi alternatif terapi dalam penanganan CARDS. Kasus: Perempuan usia 49 tahun, masuk ICU dengan diagnosa POH-4 Craniectomy evakuasi tumor sphenoid, Sepsis Syok dan Covid-19 terkonfirmasi. Pada pemeriksaan didapatkan hipoksemia dengan ARDS berat P/F ratio 112.1 mmHg dan gambaran pneumonia dextra dan efusi pleura dextra.  Sebelum pindah ke ICU Covid, pasien mendapatkan terapi HFNC FiO2 40% dengan flow 35 L/menit, RR 25, Saturasi 95%, ROX index 9,5. Pemeriksaan laboratorium didapatkan Wbc : 7.800/L, Hb: 8,1mg/dl, Plt : 131.000/mm3, Bilirubin total 1,3 mg/dl, bilirubin direct 0,83 mg/dl, Na/K/cl : 143/2,9/111, Procalcitonin : 11.2. Kesimpulan: Terapi oksigen dengan HFNC pada CARDS sedang sampai berat menjadi pilihan bijaksana dimana terapi HFNC dapat menunda intubasi dan IMV dengan outcome yang baik. Sebagaimana Surviving Sepsis/Society of Critical Care Medicine merekomendasikan HFNC sebagai pendekatan lini pertama.

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