Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial | Critical Care Medicine | JAMA | JAMA Network
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Noninvasive ventilation (NIV) may help COVID-19 patients in respiratory failure avoid invasive mechanical ventilation but may also lead to delays in intubation with potential for worse clinical outcomes.Domenico L. Grieco, MD, of Fondazione Policlinico Agostino Gemelli IRCCS in Rome, Jesse B. Hall, MD, of the University of Chicago, and Laveena Munshi, MD, MSc, of Sinai Health System/University Health Network of the University of Toronto join JAMA's live Q&A series to discuss helmet NIV, high-flow nasal oxygen, and other NIV modalities in the management of hypoxic coronavirus patients. Recorded March 25, 2021....

1.
Rochwerg  B, Brochard  L, Elliott  MW,  et al.  Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure.   Eur Respir J. 2017;50(2):1602426. doi:10.1183/13993003.02426-2016 PubMedGoogle Scholar
2.
Yoshida  T, Fujino  Y, Amato  MBP, Kavanagh  BP.  Fifty years of research in ARDS: spontaneous breathing during mechanical ventilation: risks, mechanisms, and management.   Am J Respir Crit Care Med. 2017;195(8):985-992. doi:10.1164/rccm.201604-0748CPPubMedGoogle ScholarCrossref
3.
Grieco  DL, Menga  LS, Eleuteri  D, Antonelli  M.  Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support.   Minerva Anestesiol. 2019;85(9):1014-1023. doi:10.23736/S0375-9393.19.13418-9 PubMedGoogle ScholarCrossref
4.
Bellani  G, Laffey  JG, Pham  T,  et al; LUNG SAFE Investigators; ESICM Trials Group.  Noninvasive ventilation of patients with acute respiratory distress syndrome: insights from the LUNG SAFE Study.   Am J Respir Crit Care Med. 2017;195(1):67-77. doi:10.1164/rccm.201606-1306OC PubMedGoogle ScholarCrossref
5.
Franco  C, Facciolongo  N, Tonelli  R,  et al.  Feasibility and clinical impact of out-of-ICU noninvasive respiratory support in patients with COVID-19-related pneumonia.   Eur Respir J. 2020;56(5):2002130. doi:10.1183/13993003.02130-2020 PubMedGoogle Scholar
6.
Grasselli  G, Zangrillo  A, Zanella  A,  et al; COVID-19 Lombardy ICU Network.  Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region, Italy.   JAMA. 2020;323(16):1574-1581. doi:10.1001/jama.2020.5394 PubMedGoogle ScholarCrossref
7.
COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators.  Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study.   Intensive Care Med. 2021;47(1):60-73. doi:10.1007/s00134-020-06294-x PubMedGoogle ScholarCrossref
8.
Rochwerg  B, Einav  S, Chaudhuri  D,  et al.  The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline.   Intensive Care Med. 2020;46(12):2226-2237. doi:10.1007/s00134-020-06312-y PubMedGoogle ScholarCrossref
9.
Mellado-Artigas  R, Ferreyro  BL, Angriman  F,  et al; COVID-19 Spanish ICU Network.  High-flow nasal oxygen in patients with COVID-19-associated acute respiratory failure.   Crit Care. 2021;25(1):58. doi:10.1186/s13054-021-03469-w PubMedGoogle ScholarCrossref
10.
Patel  BK, Wolfe  KS, Pohlman  AS, Hall  JB, Kress  JP.  Effect of noninvasive ventilation delivered by helmet vs face mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome: a randomized clinical trial.   JAMA. 2016;315(22):2435-2441. doi:10.1001/jama.2016.6338 PubMedGoogle ScholarCrossref
11.
Ferreyro  BL, Angriman  F, Munshi  L,  et al.  Association of noninvasive oxygenation strategies with all-cause mortality in adults with acute hypoxemic respiratory failure: a systematic review and meta-analysis.   JAMA. 2020;324(1):57-67. doi:10.1001/jama.2020.9524 PubMedGoogle ScholarCrossref
12.
Antonelli  M, Conti  G, Pelosi  P,  et al.  New treatment of acute hypoxemic respiratory failure: noninvasive pressure support ventilation delivered by helmet: a pilot controlled trial.   Crit Care Med. 2002;30(3):602-608. doi:10.1097/00003246-200203000-00019 PubMedGoogle ScholarCrossref
13.
Morais  CCA, Koyama  Y, Yoshida  T,  et al.  High positive end-expiratory pressure renders spontaneous effort noninjurious.   Am J Respir Crit Care Med. 2018;197(10):1285-1296. doi:10.1164/rccm.201706-1244OC PubMedGoogle ScholarCrossref
14.
Yoshida  T, Grieco  DL, Brochard  L, Fujino  Y.  Patient self-inflicted lung injury and positive end-expiratory pressure for safe spontaneous breathing.   Curr Opin Crit Care. 2020;26(1):59-65. doi:10.1097/MCC.0000000000000691 PubMedGoogle ScholarCrossref
15.
Grieco  DL, Menga  LS, Raggi  V,  et al.  Physiological comparison of high-flow nasal cannula and helmet noninvasive ventilation in acute hypoxemic respiratory failure.   Am J Respir Crit Care Med. 2020;201(3):303-312. doi:10.1164/rccm.201904-0841OC PubMedGoogle ScholarCrossref
16.
Grieco  DL, Toni  F, Santantonio  MT,  et al.  Comfort during high-flow oxygen therapy through nasal cannula in critically ill patients: effects of gas temperature and flow.  Presented at the 26th Annual Congress of the European Society of Intensive Medicine; October 5-9, 2013; Paris, France.
17.
Muriel  A, Peñuelas  O, Frutos-Vivar  F,  et al.  Impact of sedation and analgesia during noninvasive positive pressure ventilation on outcome: a marginal structural model causal analysis.   Intensive Care Med. 2015;41(9):1586-1600. doi:10.1007/s00134-015-3854-6 PubMedGoogle ScholarCrossref
18.
Coppo  A, Bellani  G, Winterton  D,  et al.  Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study.   Lancet Respir Med. 2020;8(8):765-774. doi:10.1016/S2213-2600(20)30268-X PubMedGoogle ScholarCrossref
19.
Frat  J-P, Thille  AW, Mercat  A,  et al; FLORALI Study Group; REVA Network.  High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure.   N Engl J Med. 2015;372(23):2185-2196. doi:10.1056/NEJMoa1503326 PubMedGoogle ScholarCrossref
20.
Antonelli  M, Conti  G, Rocco  M,  et al.  A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure.   N Engl J Med. 1998;339(7):429-435. doi:10.1056/NEJM199808133390703 PubMedGoogle ScholarCrossref
21.
Fan  E, Del Sorbo  L, Goligher  EC,  et al; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine.  An official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine clinical practice guideline: mechanical ventilation in adult patients with acute respiratory distress syndrome.   Am J Respir Crit Care Med. 2017;195(9):1253-1263. doi:10.1164/rccm.201703-0548ST PubMedGoogle ScholarCrossref
22.
Boles  J-M, Bion  J, Connors  A,  et al.  Weaning from mechanical ventilation.   Eur Respir J. 2007;29(5):1033-1056. doi:10.1183/09031936.00010206 PubMedGoogle ScholarCrossref
23.
Maggiore  SM, Idone  FA, Vaschetto  R,  et al.  Nasal high-flow versus Venturi mask oxygen therapy after extubation: effects on oxygenation, comfort, and clinical outcome.   Am J Respir Crit Care Med. 2014;190(3):282-288. doi:10.1164/rccm.201402-0364OC PubMedGoogle ScholarCrossref
24.
Menga  LS, Cese  LD, Bongiovanni  F,  et al.  High failure rate of noninvasive oxygenation strategies in critically ill subjects with acute hypoxemic respiratory failure due to COVID-19.   Respir Care. 2021;(March):respcare.08622. doi:10.4187/respcare.08622 PubMedGoogle Scholar
25.
Carrillo  A, Gonzalez-Diaz  G, Ferrer  M,  et al.  Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure.   Intensive Care Med. 2012;38(3):458-466. doi:10.1007/s00134-012-2475-6 PubMedGoogle ScholarCrossref
26.
Hilbert  G, Gruson  D, Vargas  F,  et al.  Noninvasive ventilation in immunosuppressed patients with pulmonary infiltrates, fever, and acute respiratory failure.   N Engl J Med. 2001;344(7):481-487. doi:10.1056/NEJM200102153440703 PubMedGoogle ScholarCrossref
27.
Ferrer  M, Esquinas  A, Leon  M, Gonzalez  G, Alarcon  A, Torres  A.  Noninvasive ventilation in severe hypoxemic respiratory failure: a randomized clinical trial.   Am J Respir Crit Care Med. 2003;168(12):1438-1444. doi:10.1164/rccm.200301-072OC PubMedGoogle ScholarCrossref
28.
Demoule  A, Chevret  S, Carlucci  A,  et al; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation).  Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries.   Intensive Care Med. 2016;42(1):82-92. doi:10.1007/s00134-015-4087-4 PubMedGoogle ScholarCrossref
29.
Demoule  A, Girou  E, Richard  J-C, Taille  S, Brochard  L.  Benefits and risks of success or failure of noninvasive ventilation.   Intensive Care Med. 2006;32(11):1756-1765. doi:10.1007/s00134-006-0324-1 PubMedGoogle ScholarCrossref
30.
Ferrer  M, Esquinas  A, Arancibia  F,  et al.  Noninvasive ventilation during persistent weaning failure: a randomized controlled trial.   Am J Respir Crit Care Med. 2003;168(1):70-76. doi:10.1164/rccm.200209-1074OC PubMedGoogle ScholarCrossref
31.
Brochard  L, Slutsky  A, Pesenti  A.  Mechanical ventilation to minimize progression of lung injury in acute respiratory failure.   Am J Respir Crit Care Med. 2017;195(4):438-442. doi:10.1164/rccm.201605-1081CP PubMedGoogle ScholarCrossref
32.
Goligher  EC, Dres  M, Patel  BK,  et al.  Lung- and diaphragm-protective ventilation.   Am J Respir Crit Care Med. 2020;202(7):950-961. doi:10.1164/rccm.202003-0655CP PubMedGoogle ScholarCrossref
33.
Tonelli  R, Fantini  R, Tabbì  L,  et al.  Early inspiratory effort assessment by esophageal manometry predicts noninvasive ventilation outcome in de novo respiratory failure: a pilot study.   Am J Respir Crit Care Med. 2020;202(4):558-567. doi:10.1164/rccm.201912-2512OC PubMedGoogle ScholarCrossref
34.
Antonelli  M, Conti  G, Esquinas  A,  et al.  A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome.   Crit Care Med. 2007;35(1):18-25. doi:10.1097/01.CCM.0000251821.44259.F3 PubMedGoogle ScholarCrossref
35.
Carteaux  G, Millán-Guilarte  T, De Prost  N,  et al.  Failure of noninvasive ventilation for de novo acute hypoxemic respiratory failure: role of tidal volume.   Crit Care Med. 2016;44(2):282-290. doi:10.1097/CCM.0000000000001379 PubMedGoogle ScholarCrossref
36.
Demoule  A, Vieillard Baron  A, Darmon  M,  et al.  High-flow nasal cannula in critically iii patients with severe COVID-19.   Am J Respir Crit Care Med. 2020;202(7):1039-1042. doi:10.1164/rccm.202005-2007LE PubMedGoogle ScholarCrossref
37.
Zucman  N, Mullaert  J, Roux  D, Roca  O, Ricard  J-D; Contributors.  Prediction of outcome of nasal high flow use during COVID-19–related acute hypoxemic respiratory failure.   Intensive Care Med. 2020;46(10):1924-1926. doi:10.1007/s00134-020-06177-1 PubMedGoogle ScholarCrossref
38.
Goligher  EC, Fan  E, Herridge  MS,  et al.  Evolution of diaphragm thickness during mechanical ventilation: impact of inspiratory effort.   Am J Respir Crit Care Med. 2015;192(9):1080-1088. doi:10.1164/rccm.201503-0620OC PubMedGoogle ScholarCrossref
39.
Herridge  MS, Cheung  AM, Tansey  CM,  et al; Canadian Critical Care Trials Group.  One-year outcomes in survivors of the acute respiratory distress syndrome.   N Engl J Med. 2003;348(8):683-693. doi:10.1056/NEJMoa022450 PubMedGoogle ScholarCrossref
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    4 Comments for this article
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    The Real Effects of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Oxygenation in COVID-19
    Andrey Yaroshetskiy, MD, PhD, ScD | Sechenov University
    We have read with great interest the first and the only randomized clinical trial comparing non-invasive helmet ventilation (NIV) and high-flow nasal oxygen (HFNO) in patients with COVID-19-associated acute respiratory failure (ARF). Actually, all of us were waiting for such a comparison to improve the outcomes of our patients. We congratulate the authors for this original contribution in such a short time.
    However, calculation of the ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) measurement on Venturi masks before randomization can aggravate the severity of ARF. We know that admixture of inspired air in patients
    with hypoxemic ARF, high respiratory drive, and high peak inspiratory flow leads to a decrease in actual inspiratory oxygen fraction (1). This effect can be clearly seen in Figure 4 where authors changed Venturi mask to positive airway pressure delivered by a «compressed gas-based ventilator connected to the helmet through a bi-tube circuit».

    Thus, the increase in PaO2/FiO2 can be at least partially be explained by the correct measurement of FiO2 in the ventilator circuit, rather than lung recruitment. Authors reported a success rate for NIV of about 70% in patients with initial PaO2/FiO2 105 mmHg. If we compare these results with previous NIV studies using helmets we can easily see that helmet CPAP increased PaO2/FiO2 from about 100 till 200 mmHg (2), and the real NIV success rate in patients with PaO2/FiO2 <100 mmHg was only 22%. In another ‘helmet’ study (3) intubation rate in patients with PaO2/FiO2 < 150 was 53%, two-times higher than in the present study. The same underestimation of the initial PaO2/FiO2 can be proposed for HFNO group.

    If we focus not only on oxygenation, but also on CO2 removal, we have to calculate the ROX index or ventilation ratio (4). We know that ROX index <4.88 is an independent predictor of HFNO (and possibly NIV) failure. We tried to calculate this index using the data in Table 1 for the medians: SpO2 95%/FiO2 50% /RR 28 = 6.78 (that means low risk of intubation). If we recalculate this for PaO2 / FiO2 100 mmHg, we see a different result: SpO2 95% /FiO2 75% /RR 28 = 4.52 (high risk of HFO / NIV failure), which is not in line with the results presented.

    We again applaud the authors and thank them for the great pleasure of reading this text.

    References:
    1. Coudroy R, Frat JP, Girault C, Thille AW. Reliability of methods to estimate the fraction of inspired oxygen in patients with acute respiratory failure breathing through non-rebreather reservoir bag oxygen mask. Thorax. 2020 Sep;75(9):805-807. doi: 10.1136/thoraxjnl-2020-214863.
    2. Coppadoro A, Benini A, Fruscio R, et al. Helmet CPAP to treat hypoxic pneumonia outside the ICU: an observational study during the COVID-19 outbreak. Crit Care. 2021 Feb 24;25(1):80. doi: 10.1186/s13054-021-03502-y.
    3. Bellani G, Grasselli G, Cecconi M, et al. Noninvasive Ventilatory Support of COVID-19 Patients Outside the Intensive Care Units (WARd-COVID). Ann Am Thorac Soc. 2021 Jan 4. doi: 10.1513/AnnalsATS.202008-1080OC. Epub ahead of print.
    4. Roca O, Caralt B, Messika J, et al. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.
    CONFLICT OF INTEREST: None Reported
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    Reporting and Representation of Obesity in RCTs of Noninvasive Respiratory Support in AHRF
    Tim Gaulton, MD, MSc | University of Pennsylvania, Department of Anesthesiology and Critical Care
    We applaud the tremendous work of Grieco and colleagues to provide crucial evidence that aids in the selection of noninvasive respiratory support for patients with COVID-19 pneumonia. We raise a few questions that need clarification regarding the representation of and generalizability to patients with obesity in this randomized controlled trial (RCT). First, what was the proportion of patients with obesity, defined as a body mass index ≥ 30 kg/m2? Second, did the primary outcome and intubation rate differ by patient BMI? Third, what was the rationale for excluding patients with class III or extreme obesity (BMI ≥ 40 kg/m2)

    Obesity, and in particular extreme obesity, is associated with acute hypoxemic respiratory failure (AHRF) and mortality from COVID-19 (1).  In the United States, over half of critically ill patients with COVID-19 are obese and up to 10% have extreme obesity (1).  Obese patients have distinct impairments in respiratory mechanics compared to normal weight patients – abdominal adiposity raises pleural pressure with a downstream reduction in transpulmonary pressure that increases susceptibility to alveolar collapse in this population (2). Ventilation strategies that allow for alveolar recruitment and positive end expiratory pressure may embrace particular benefit in obese patients, as has been shown within invasive ventilation in acute respiratory distress syndrome (3).  Would we therefore see a more significant increase in ventilator-free days in obese patients with the use of helmet treatment, a noninvasive strategy that generates high alveolar pressure, compared to high-flow nasal oxygen?

    Gaps in the reporting and representation of obesity in trials of noninvasive respiratory support in AHRF are common. From a recent systematic review and meta-analysis of 25 RCTs comparing noninvasive respiratory support strategies that was published in JAMA (4), just 7 of the trials reported participant BMI and only 1 reported the proportion of enrolled obese participants. 2 of the trials excluded patients with extreme obesity. None of the trials performed subgroup analyses by obesity class.

    We raise significant concern on the lack of reporting and potential representation of obesity in trials on noninvasive respiratory support in AHRF including now the trial by Grieco et al, preventing a crucial adoption of evidence-based treatments to patients with obesity who are a highly prevalent and vulnerable population within AHRF. Current and future trials assessing noninvasive respiratory support for AHRF, including those involving COVID-19, need explicit reporting of participant obesity classes and need to target obesity enrollment and analyses.

    References

    1. Tartof SY, Qian L, Hong V, et al. Obesity and Mortality Among Patients Diagnosed With COVID-19: Results From an Integrated Health Care Organization. Ann Intern Med. 2020;173(10):773-781.
    2. De Jong A, Wrigge H, Hedenstierna G, et al. How to ventilate obese patients in the ICU. Intensive Care Med. 2020 Dec 1;46(12):2423–35.
    3. De Santis Santiago R, Teggia Droghi M, Fumagalli J, Marrazzo F, et al. Lung Rescue Team Investigators. High Pleural Pressure Prevents Alveolar Overdistension and Hemodynamic Collapse in ARDS with Class III Obesity. Am J Respir Crit Care Med. 2020 Sep 2;203(5):575–84.
    4. Ferreyro BL, Angriman F, Munshi L, et al. Association of Noninvasive Oxygenation Strategies With All-Cause Mortality in Adults With Acute Hypoxemic Respiratory Failure: A Systematic Review and Meta-analysis. JAMA. 2020 07;324(1):57–67
    CONFLICT OF INTEREST: None Reported
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    NIV in Moderate to Severe COVID-19: Not Always, Not for Everyone?
    Enrico Clini, MD, Professor | University of Modena and Reggio Emilia, Italy
    We read with interest the study by Grieco and coworkers which appeared in JAMA (1). This was the first head-to-head comparison of helmet noninvasive ventilation (NIV) and high-flow nasal oxygen (HFNO) to treat hospitalized moderate to severe COVID-19 ARDS (CARDS) at early onset, but failed to show any difference in the primary (days free from respiratory support at 1-month) and most of the secondary outcomes, leaving readers without a clear clinical message. Indeed, the authors suggest that further studies with a different pre-specified outcome is warranted.

    Beyond the main result, it is of greater clinical interest and quite surprising
    that, despite the fact that the intubation rate was significantly higher with HFNO compared to NIV (51% vs 30%), no difference in 28- and 60-day mortality was observed. Patients enrolled presented severe CARDS (median PaO2/FIO2 ratio 102-105 mmHg with bilateral lung infiltrates), associated with relatively low respiratory drive activation (respiratory rate 28 b/m, PaCO2 34 mmHg, VAS-dyspnea 4) as compared to similar forms of typical ARDS (2). This might suggest that so called “silent hypoxemia” (3) was present, at least in a proportion of patients subjected to NIV, thus reducing the benefit of noninvasive ventilation in relieving inspiratory effort and preventing self-inflicted lung injury (SILI).

    Moreover, the authors report an increase in PaO2/FIO2 ratio over the first 48 hours in the NIV group, thus suggesting a beneficial effect on alveolar recruitment. However, comparing these CARDS patients with patients with ARDS of similar severity (2,4), different respiratory rates are associated with a similar PaCO2 level, indicating a low amount of dead space ventilation and less severe intrapulmonary shunt due to alveolar collapse (no data on tidal volume are reported). Studies exploring the respiratory mechanics found an overlap with typical ARDS in invasively ventilated CARDS patients, which is not representative of the early onset of the disease, when spontaneous breathing is still preserved. At this stage, we could speculate that CARDS patients might behave differently, with relatively spared inspiratory effort and less potential lung recruitment with an increased risk of alveolar overdistention under NIV. It is likely that application of NIV (with PEEP set at <10cmH2O) might have represented a mechanical disadvantage in a subset of CARDS patients, thus justifying a similar mortality even with lower intubation rate compared with HFNO. Physiological studies in spontaneously breathing CARDS are still needed to explore these issues and to better address clinicians in decision making process.

    References

    1. Grieco DL, Menga LS, Cesarano M, et a. COVID-ICU Gemelli Study Group. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial. JAMA. 2021 Mar 25. doi: 10.1001/jama.2021.4682. Epub ahead of print.
    2. Tonelli R, Fantini R, Tabbì L, et al. Inspiratory Effort Assessment by Esophageal Manometry Early Predicts Noninvasive Ventilation Outcome in de novo Respiratory Failure: A Pilot Study. Am J Respir Crit Care Med. 2020; 202(4): 558-567.
    3. Couzin-Frankel J. The mystery of the pandemic's 'happy hypoxia'. Science 2020; 368(6490): 455–456.
    4. Carteaux G, Millán-Guilarte T, De Prost N, et al. Failure of Noninvasive Ventilation for De Novo Acute Hypoxemic Respiratory Failure: Role of Tidal Volume. Crit Care Med. 2016; 44(2
    CONFLICT OF INTEREST: None Reported
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    Choice of Noninvasive Respiratory Support for Hypoxemic Respiratory Failure in Covid-19
    Claudia Brusasco, M.D., Ph.D | Ente Ospedaliero Ospedali Galliera. Genova. Italy
    We read with great interest the recent paper by Grieco et al.(1) on helmet noninvasive ventilation (NIV) in moderate-to-severe hypoxemic respiratory failure due to with Covid-19 pneumonia. While NIV has been recommended for acute hypercapnic respiratory failure and acute cardiogenic pulmonary edema (2), no recommendation has been made for hypoxemic respiratory failure and, in particular, for viral pandemics because of lack of randomized studies showing its efficacy and concerns of infection dissemination. In this context, the study by Grieco et al. (1) has the merit of being the first randomized controlled trial comparing NIV with high-flow nasal oxygen in Covid-19. Although the two treatments were not significantly different for the primary outcome, i.e., days free of respiratory support, the rate of intubation was significantly less in patients treated by NIV with median positive end-expiratory pressure (PEEP) of 12 cmH2O and pressure support of 10 cmH2O). However, 30 percent of NIV-treated patients were eventually intubated within 28 days and 24 percent died. These figures are approximately twice larger than those found in an observational study of our group using helmet or face mask continuous positive airway pressure (CPAP) of 10 cmH2O in patients with similar characteristics (3).

    Although different pharmacological treatments and intubation criteria might have contributed to the difference in outcome between the two studies, the findings raise a question about whether pressure support in these patients is necessary or might be even detrimental. Patients with acute hypoxemic respiratory failure due to Covid-19 generally have normo- or hypocapnia, suggesting self-sufficient respiratory drive and pump function. Indeed, the trend of PaCO2 in the NIV group shows no benefit in terms of alveolar ventilation, possibly due to tidal volume preferentially delivered to regions with already high ventilation-to-perfusion ratio. Over-distension of these regions may cause redistribution of blood flow to regions of low ventilation-to-perfusion ratio, thus increasing venous admixture and obscuring the advantage of recruitment on arterial oxygenation. This in addition to patients' discomfort may prompt the physician in charge to make the decision to intubate. It is worth noting that none of the subjects in our observational study (3) underwent intubation because of intolerance to CPAP or required sedation. Although a large randomized clinical trial comparing CPAP with high flow nasal oxygen is currently ongoing across the UK (4) we think a direct comparison between CPAP and NIV with pressure support is warranted.

    References

    1. Grieco DL, Menga LS, Cesarano M et al. Effect of Helmet Noninvasive Ventilation vs High-FlowNasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory FailureThe HENIVOT Randomized Clinical Trial. JAMA. doi:10.1001/jama.2021.4682.
    2. Rochwerg B, Brochard L, Elliott MW, et al. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur. Respir. J. 2017;50(2):1602426. doi:10.1183/13993003.02426-2016.
    3. Brusasco C, Corradi F, Di Domenico A, et al. Continuous positive airway pressure in Covid-19 patients with moderate-to-severe respiratory failure. Eur Respir J. 2021;57(2):2002524. doi: 10.1183/13993003.02524-2020.
    4. Perkins GD, Couper K, Connolly B et al: RECOVERY- Respiratory Support: Respiratory Strategies for patients with suspected or proven COVID-19 respiratory failure; Continuous Positive Airway Pressure, High-flow
    CONFLICT OF INTEREST: None Reported
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    Original Investigation
    Caring for the Critically Ill Patient
    March 25, 2021

    Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial

    Author Affiliations
    • 1Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario AGemelli IRCCS, Rome, Italy
    • 2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
    • 3Department of Morphology, Surgery, and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant’Anna, University of Ferrara, Ferrara, Italy
    • 4Department of Anaesthesia and Intensive Care, Infermi Hospital, Rimini, Italy
    • 5Dipartimento di Scienze Mediche e Chirurgiche, Anesthesia and Intensive Care Medicine, Policlinico di Sant’Orsola, Alma Mater Studiorum–Università di Bologna, Bologna, Italy
    • 6European School of Obstetric Anesthesia, EESOA Simulation Center, Rome, Italy
    • 7University Department of Innovative Technologies in Medicine and Dentistry, Gabriele d’Annunzio University of Chieti-Pescara, Chieti, Italy
    • 8Department of Anesthesiology, Critical Care Medicine, and Emergency, SS Annunziata Hospital, Chieti, Italy
    JAMA. 2021;325(17):1731-1743. doi:10.1001/jama.2021.4682
    Visual Abstract. Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen in COVID-19 and Moderate to Severe Hypoxemia
    Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen in COVID-19 and Moderate to Severe Hypoxemia
    Conversations with Dr Bauchner (32:15)
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    Key Points

    Question  Among patients admitted to the intensive care unit with COVID-19–induced moderate to severe hypoxemic respiratory failure, does early continuous treatment with helmet noninvasive ventilation increase the number of days free of respiratory support at 28 days as compared with high-flow nasal oxygen?

    Findings  In this randomized trial that included 109 patients, the median number of days free of respiratory support within 28 days was 20 days in the group that received helmet noninvasive ventilation and 18 days in the group that received high-flow nasal oxygen, a difference that was not statistically significant.

    Meaning  Among critically ill patients with moderate to severe hypoxemic respiratory failure due to COVID-19, helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days.

    Abstract

    Importance  High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19.

    Objective  To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone.

    Design, Setting, and Participants  Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200).

    Interventions  Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55).

    Main Outcomes and Measures  The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay.

    Results  Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, −2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, −21% [95% CI, −38% to −3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, −1% [95% CI, −17% to 15%]; P > .99).

    Conclusions and Relevance  Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation.

    Trial Registration  ClinicalTrials.gov Identifier: NCT04502576

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