Noninvasive ventilation with helmet versus control strategy in patients with acute respiratory failure: a systematic review and meta-analysis of controlled studies

Qi Liu, Yonghua Gao, Rongchang Chen, Zhe Cheng, Qi Liu, Yonghua Gao, Rongchang Chen, Zhe Cheng

Abstract

Background: Noninvasive ventilation (NIV) has proved to be a useful technique for breathing support. However, complications, discomfort, and failure of NIV were commonly caused by the mask. Therefore, the helmet was developed to improve performance and reduce complications; however, there has been no conclusive results on its effect until now. Thus, we performed a systematic review and meta-analysis to investigate the effect of NIV with a helmet versus the control strategy in patients with acute respiratory failure (ARF).

Methods: We searched Cochrane Library, PubMed, Ovid, and Embase databases and bibliographies of relevant articles published before June 2016. Randomized and case-control studies that adopted the helmet as an NIV interface and compared it with another interface were included. The primary outcomes were hospital mortality, intubation rate, and complications. The secondary outcomes included the length of intensive care unit (ICU) stay, gas exchange, and respiratory rate. Pooled odds ratios (ORs) and 95 % confidence intervals (CIs) were calculated by the Mantel-Haenszel method and mean difference by the inverse variance method in a fixed effect model or random effects model according to the heterogeneity.

Results: A total of 11 studies involving 621 patients were included. The overall hospital mortality was 17.53 % in the helmet NIV group versus 30.67 % in the control group. Use of the helmet was associated with lower hospital mortality (OR 0.43, 95 % CI 0.26 to 0.69, p = 0.0005), intubation rate (OR 0.32, 95 % CI 0.21 to 0.47, P < 0.00001), and complications (OR 0.6, 95 % CI 0.4 to 0.92, P = 0.02). In contrast, there was no significant difference in gas exchange and ICU stay (P >0.05). Subgroup analysis found the helmet reduced mortality mainly in hypoxemic ARF patients (P < 0.05) and a lower intubation rate was shown in randomized trials; fewer complications caused by the helmet might be restricted to case-control trials. Additionally, the effect of the helmet on PaCO2 was influenced by type of ARF and ventilation mode (P <0.00001).

Conclusion: NIV with a helmet was associated with reduced hospital mortality and intubation requirement. The helmet was as effective as the mask in gas exchange with no additional advantage. Large randomized controlled trials are needed to provide more robust evidence.

Keywords: Facial mask; Helmet; Noninvasive ventilation.

Figures

Fig. 1
Fig. 1
Flow chart showing the selection of studies in this meta-analysis
Fig. 2
Fig. 2
Effect of NIV with a helmet on primary outcomes and length of ICU stay. The helmet NIV group represents patients receiving NIV with a helmet, the control group represent patients receiving NIV with a mask or oxygen therapy with a mask. Vertical solid line null effect, boxes and horizontal lines outcome in the corresponding study and 95 % CI, filled rhombic boxes overall effect size. a Effect of NIV with a helmet on hospital mortality; b effect of NIV with a helmet on intubation rate; c effect of NIV with a helmet on complications; d effect of NIV with a helmet on length of ICU stay. CI confidence interval, ICU intensive care unit, IV inverse variance method, NIV noninvasive ventilation, M-H Mantel-Haenszel method, SD standard deviation
Fig. 3
Fig. 3
Effect of NIV with a helmet on the gas exchange and respiratory rate. The helmet NIV group represents patients receiving NIV with a helmet, the control group represent patients receiving NIV with mask or oxygen therapy with mask. Vertical solid line null effect, boxes and horizontal lines outcome in the corresponding study and 95 % CI, filled rhombic boxes overall effect size. a Effect of NIV with a helmet on oxygenation; b effect of NIV a with helmet on pH; c effect of NIV with a helmet on PaCO2; d effect of NIV with a helmet on respiratory rate. CI confidence interval, IV inverse variance method, NIV noninvasive ventilation, PaCO2 partial pressure of carbon dioxide in arterial blood, P/F the ratio of partial pressure of oxygenation in arterial blood to fraction of inspired oxygenation, SD standard deviation,
Fig. 4
Fig. 4
Funnel plots to assess publication bias regarding the effect of NIV with a helmet on hospital mortality. SE standard error, OR odds ratio

References

    1. Lindenauer PK, Stefan MS, Shieh MS, Pekow PS, Rothberg MB, Hill NS. Outcomes associated with invasive and noninvasive ventilation among patients hospitalized with exacerbations of chronic obstructive pulmonary disease. JAMA Intern Med. 2014;174:1982–93. doi: 10.1001/jamainternmed.2014.5430.
    1. Masip J, Roque M, Sánchez B, Fernández R, Subirana M, Expósito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005;294:3124–30. doi: 10.1001/jama.294.24.3124.
    1. Duggal A, Perez P, Golan E, Tremblay L, Sinuff T. Safety and efficacy of noninvasive ventilation in patients with blunt chest trauma: a systematic review. Crit Care. 2013;17:R142. doi: 10.1186/cc12821.
    1. Nava S. Behind a mask: tricks, pitfalls, and prejudices for noninvasive ventilation. Respir Care. 2013;58:1367–76. doi: 10.4187/respcare.02457.
    1. Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, et al. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008;177:170–7. doi: 10.1164/rccm.200706-893OC.
    1. Lee JS, O'Dochartaigh D, MacKenzie M, Hudson D, Couperthwaite S, Villa-Roel C, Rowe BH. Factors associated with failure of non-invasive positive pressure ventilation in a critical care helicopter emergency medical service. Prehosp Disaster Med. 2015;30:239–43. doi: 10.1017/S1049023X15000199.
    1. Carron M, Freo U, BaHammam AS, Dellweg D, Guarracino F, Cosentini R, Feltracco P, Vianello A, Ori C, Esquinas A. Complications of non-invasive ventilation techniques: a comprehensive qualitative review of randomized trials. Br J Anaesth. 2013;110:896–914. doi: 10.1093/bja/aet070.
    1. Sferrazza PGF, Di MF, Akoumianaki E, Brochard L. Recent advances in interfaces for non-invasive ventilation: from bench studies to practical issues. Minerva Anestesiol. 2012;78:1146–53.
    1. Maruccia M, Ruggieri M, Onesti MG. Facial skin breakdown in patients with non-invasive ventilation devices: report of two cases and indications for treatment and prevention. Int Wound J. 2015;12:451–5. doi: 10.1111/iwj.12135.
    1. Yamaguti WP, Moderno EV, Yamashita SY, Gomes TG, Maida AL, Kondo CS, de Salles IC, de Brito CM. Treatment-related risk factors for development of skin breakdown in subjects with acute respiratory failure undergoing noninvasive ventilation or CPAP. Respir Care. 2014;59:1530–6. doi: 10.4187/respcare.02942.
    1. Kramer N, Meyer TJ, Meharg J, Cece RD, Hill NS. Randomized, prospective trial of noninvasive positive pressure ventilation in acute respiratory failure. Am J Respir Crit Care Med. 1995;151:1799–806. doi: 10.1164/ajrccm.151.6.7767523.
    1. Lemyze M, Mallat J, Nigeon O, Barrailler S, Pepy F, Gasan G, Vangrunderbeeck N, Grosset P, Tronchon L, Thevenin D. Rescue therapy by switching to total face mask after failure of face mask-delivered noninvasive ventilation in do-not-intubate patients in acute respiratory failure. Crit Care Med. 2013;41:481–8. doi: 10.1097/CCM.0b013e31826ab4af.
    1. Pelosi P, Severgnini P, Aspesi M, Gamberoni C, Chiumello D, Fachinetti C, Introzzi L, Antonelli M, Chiaranda M. Non-invasive ventilation delivered by conventional interfaces and helmet in the emergency department. Eur J Emerg Med. 2003;10:79–86. doi: 10.1097/00063110-200306000-00002.
    1. Antonelli M, Conti G, Pelosi P, Gregoretti C, Pennisi MA, Costa R, Severgnini P, Chiaranda M, Proietti R. New treatment of acute hypoxemic respiratory failure: noninvasive pressure support ventilation delivered by helmet--a pilot controlled trial. Crit Care Med. 2002;30:602–8. doi: 10.1097/00003246-200203000-00019.
    1. Pisani L, Mega C, Vaschetto R, Bellone A, Scala R, Cosentini R, Musti M, Del FM, Grassi M, Fasano L, et al. Oronasal mask versus helmet in acute hypercapnic respiratory failure. Eur Respir J. 2015;45:691–9. doi: 10.1183/09031936.00053814.
    1. Brambilla AM, Aliberti S, Prina E, Nicoli F, Del FM, Nava S, Ferrari G, Corradi F, Pelosi P, Bignamini A, et al. Helmet CPAP vs. oxygen therapy in severe hypoxemic respiratory failure due to pneumonia. Intensive Care Med. 2014;40:942–9. doi: 10.1007/s00134-014-3325-5.
    1. Principi T, Pantanetti S, Catani F, Elisei D, Gabbanelli V, Pelaia P, Leoni P. Noninvasive continuous positive airway pressure delivered by helmet in hematological malignancy patients with hypoxemic acute respiratory failure. Intensive Care Med. 2004;30:147–50. doi: 10.1007/s00134-003-2056-9.
    1. Barbagallo M, Ortu A, Spadini E, Salvadori A, Ampollini L, Internullo E, Ziegler S, Fanelli G. Prophylactic use of helmet CPAP after pulmonary lobectomy: a prospective randomized controlled study. Respir Care. 2012;57:1418–24.
    1. Belenguer-Muncharaz A, Reig-Valero R, Altaba-Tena S, Casero-Roig P, Ferrándiz-Sellés A. Noninvasive mechanical ventilation in severe pneumonia due to H1N1 virus. Med Intensiva. 2011;35:470–7. doi: 10.1016/j.medin.2011.04.001.
    1. Antonelli M, Pennisi MA, Pelosi P, Gregoretti C, Squadrone V, Rocco M, Cecchini L, Chiumello D, Severgnini P, Proietti R, et al. Noninvasive positive pressure ventilation using a helmet in patients with acute exacerbation of chronic obstructive pulmonary disease: a feasibility study. Anesthesiology. 2004;100:16–24. doi: 10.1097/00000542-200401000-00007.
    1. Conti G, Cavaliere F, Costa R, Craba A, Catarci S, Festa V, Proietti R, Antonelli M. Noninvasive positive-pressure ventilation with different interfaces in patients with respiratory failure after abdominal surgery: a matched-control study. Respir Care. 2007;52:1463–71.
    1. Esquinas RAM, Papadakos PJ, Carron M, Cosentini R, Chiumello D. Clinical review: Helmet and non-invasive mechanical ventilation in critically ill patients. Crit Care. 2013;17:223. doi: 10.1186/cc11875.
    1. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1. doi: 10.1186/2046-4053-4-1.
    1. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–60. doi: 10.1136/bmj.327.7414.557.
    1. Higgins JPT. Green S. The Cochrane Collaboration: Cochrane Handbook for Systematic Reviews of Interventions; 2011.
    1. Stang A. Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses. Eur J Epidemiol. 2010;25:603–5. doi: 10.1007/s10654-010-9491-z.
    1. Bowden J, Tierney JF, Copas AJ, Burdett S. Quantifying, displaying and accounting for heterogeneity in the meta-analysis of RCTs using standard and generalised Q statistics. BMC Med Res Methodol. 2011;11:41. doi: 10.1186/1471-2288-11-41.
    1. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539–58. doi: 10.1002/sim.1186.
    1. Ali A, Türkmen A, Turgut N, Altan A, Sari T. Comparison of non-invasive mechanical ventilation with helmet or face mask in patients with acute exacerbation of chronic obstructive pulmonary disease. Tuberk Toraks. 2011;59:146–52. doi: 10.5578/tt.738.
    1. Özlem ÇG, Ali A, Fatma U, Mehtap T, Şaziye Comparison of helmet and facial mask during noninvasive ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled study. Turk J Med Sci. 2015;45:600–6. doi: 10.3906/sag-1401-109.
    1. Antonaglia V, Ferluga M, Molino R, Lucangelo U, Peratoner A, Roman-Pognuz E, De Simoni L, Zin WA. Comparison of noninvasive ventilation by sequential use of mask and helmet versus mask in acute exacerbation of chronic obstructive pulmonary disease: a preliminary study. Respiration. 2011;82:148–54. doi: 10.1159/000324259.
    1. 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;315:2435–41. doi: 10.1001/jama.2016.6338.
    1. Tonnelier JM, Prat G, Nowak E, Goetghebeur D, Renault A, Boles JM, L'her E. Noninvasive continuous positive airway pressure ventilation using a new helmet interface: a case-control prospective pilot study. Intensive Care Med. 2003;29:2077–80. doi: 10.1007/s00134-003-1925-6.
    1. Rocco M, Dell'Utri D, Morelli A, Spadetta G, Conti G, Antonelli M, Pietropaoli P. Noninvasive ventilation by helmet or face mask in immunocompromised patients: a case-control study. Chest. 2004;126:1508–15. doi: 10.1378/chest.126.5.1508.
    1. Potts JM. Noninvasive positive pressure ventilation: effect on mortality in acute cardiogenic pulmonary edema: a pragmatic meta-analysis. Pol Arch Med Wewn. 2009;119:349–53.
    1. Lemiale V, Resche-Rigon M, Azoulay E. Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial. Trials. 2014;15:372. doi: 10.1186/1745-6215-15-372.
    1. Johnson CS, Frei CR, Metersky ML, Anzueto AR, Mortensen EM. Non-invasive mechanical ventilation and mortality in elderly immunocompromised patients hospitalized with pneumonia: a retrospective cohort study. BMC Pulm Med. 2014;14:7. doi: 10.1186/1471-2466-14-7.
    1. Schallom M, Cracchiolo L, Falker A, Foster J, Hager J, Morehouse T, Watts P, Weems L, Kollef M. Pressure ulcer incidence in patients wearing nasal-oral versus full-face noninvasive ventilation masks. Am J Crit Care. 2015;24:349–56. doi: 10.4037/ajcc2015386.
    1. Scandroglio M, Piccolo U, Mazzone E, Agrati P, Aspesi M, Gamberoni C, Severgnini P, Di SR, Chiumello D, Minoja G, et al. Use and nursing of the helmet in delivering non invasive ventilation. Minerva Anestesiol. 2002;68:475–80.
    1. Liu J, Duan J, Bai L, Zhou L. Noninvasive ventilation intolerance: characteristics, predictors, and outcomes. Respir Care. 2016;61:277–84. doi: 10.4187/respcare.04220.
    1. Silva RM, Timenetsky KT, Neves RC, Shigemichi LH, Kanda SS, Maekawa C, Silva E, Eid RA. Adaptation to different noninvasive ventilation masks in critically ill patients. J Bras Pneumol. 2013;39:469–75. doi: 10.1590/S1806-37132013000400011.
    1. Mehta S, Hill NS. Noninvasive ventilation. Am J Respir Crit Care Med. 2001;163:540–77. doi: 10.1164/ajrccm.163.2.9906116.
    1. Nicolini A, Ferraioli G, Ferrari-Bravo M, Barlascini C, Santo M, Ferrera L. Early non-invasive ventilation treatment for respiratory failure due to severe community-acquired pneumonia. Clin Respir J. 2016;10:98–103. doi: 10.1111/crj.12184.
    1. Navalesi P, Pollini A. Acute respiratory failure in patients with severe community-acquired pneumonia: a prospective randomized evaluation of noninvasive ventilation. Am J Respir Crit Care Med. 2000;162:761–2. doi: 10.1164/ajrccm.162.2.16223c.
    1. Murad A, Li PZ, Dial S, Shahin J. The role of noninvasive positive pressure ventilation in community-acquired pneumonia. J Crit Care. 2015;30:49–54. doi: 10.1016/j.jcrc.2014.09.021.
    1. Keenan SP, Mehta S. Noninvasive ventilation for patients presenting with acute respiratory failure: the randomized controlled trials. Respir Care. 2009;54:116–26.
    1. Conti G, Antonelli M, Rocco M. Noninvasive ventilation in intensive care unit patients. Monaldi Arch Chest Dis. 2000;55:50–3.
    1. Schettino G, Altobelli N, Kacmarek RM. Noninvasive positive-pressure ventilation in acute respiratory failure outside clinical trials: experience at the Massachusetts General Hospital. Crit Care Med. 2008;36:441–7. doi: 10.1097/01.CCM.0000300084.67277.90.
    1. Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012;38:458–66. doi: 10.1007/s00134-012-2475-6.
    1. Carron M, Freo U, Zorzi M, Ori C. Predictors of failure of noninvasive ventilation in patients with severe community-acquired pneumonia. J Crit Care. 2010;25:540. e9–14. doi: 10.1016/j.jcrc.2010.02.012.
    1. Olivieri C, Costa R, Spinazzola G, Ferrone G, Longhini F, Cammarota G, Conti G, Navalesi P. Bench comparative evaluation of a new generation and standard helmet for delivering non-invasive ventilation. Intensive Care Med. 2013;39:734–8. doi: 10.1007/s00134-012-2765-z.
    1. Vargas F, Thille A, Lyazidi A, Campo FR, Brochard L. Helmet with specific settings versus facemask for noninvasive ventilation. Crit Care Med. 2009;37:1921–8. doi: 10.1097/CCM.0b013e31819fff93.
    1. Olivieri C, Longhini F, Cena T, Cammarota G, Vaschetto R, Messina A, Berni P, Magnani C, Della CF, Navalesi P. New versus conventional helmet for delivering noninvasive ventilation: a physiologic, crossover randomized study in critically ill patients. Anesthesiology. 2016;124:101–8. doi: 10.1097/ALN.0000000000000910.
    1. Wysocki M, Antonelli M. Noninvasive mechanical ventilation in acute hypoxaemic respiratory failure. Eur Respir J. 2001;18:209–20. doi: 10.1183/09031936.01.00220201.
    1. Taccone P, Hess D, Caironi P, Bigatello LM. Continuous positive airway pressure delivered with a “helmet”: effects on carbon dioxide rebreathing. Crit Care Med. 2004;32:2090–6. doi: 10.1097/01.CCM.0000142577.63316.C0.
    1. Mojoli F, Iotti GA, Gerletti M, Lucarini C, Braschi A. Carbon dioxide rebreathing during non-invasive ventilation delivered by helmet: a bench study. Intensive Care Med. 2008;34:1454–60. doi: 10.1007/s00134-008-1109-5.
    1. Patroniti N, Foti G, Manfio A, Coppo A, Bellani G, Pesenti A. Head helmet versus face mask for non-invasive continuous positive airway pressure: a physiological study. Intensive Care Med. 2003;29:1680–7. doi: 10.1007/s00134-003-1931-8.
    1. Nouira S, Boukef R, Bouida W, Kerkeni W, Beltaief K, Boubaker H, Boudhib L, Grissa MH, Trimech MN, Boussarsar H, et al. Non-invasive pressure support ventilation and CPAP in cardiogenic pulmonary edema: a multicenter randomized study in the emergency department. Intensive Care Med. 2011;37:249–56. doi: 10.1007/s00134-010-2082-3.
    1. Tweedie ST. Practical estimates of the effect of publication bias in meta-analysis. Australasian Epidemiologist. 1998;5:14–7.

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