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Table 2 Summary of the clinical studies

From: Clinical review: Helmet and non-invasive mechanical ventilation in critically ill patients

Source Study design Inclusion criteria Enrolled patients Type of non-invasive ventilation Interface Control Arterial oxygenation Intubation rate Outcome Tolerance
Foti et al. (2009) [28] Observational Presumed acute cardiogenic pulmonary edema 121 CPAP Helmet O2 therapy Higher with helmet No data No data No difference
Tonnelier et al. (2003) [29] Prospective with matched control Acute cardiogenic pulmonary edema 11 CPAP Helmet FM No difference No data No data No difference
Antonelli et al. (2002) [32] Prospective with matched control Hypoxemic ARF 33 PSV Helmet FM Higher with FM No difference No difference Higher intolerance in FM versus helmet (38% versus 0%)
Cammarota et al. (2011) [36] Cross-over Hypoxemic ARF 24 CPAP with or without sigh Helmet Venturi mask Higher during sigh in bilateral lung involvement No data No data No difference
Isgrò et al. (2010) [37] Cross-over Hypoxemic ARF 21 CPAP with or without sigh and BIPAP Helmet - Higher oxygenation during sigh and BIPAP No data No data Similar tolerance
Cammarota et al. (2011) [38] Cross-over Post-extubation ARF 10 PSV - NAVA Helmet - No difference No difference No difference No data
Principi et al. (2004) [41] Prospective with historical group Hematological malignancy with hypoxemic ARF 17 CPAP Helmet FM No difference Favor helmet Favor helmet Higher intolerance in FM versus helmet (11% versus 0%)
Rocco et al. (2004) [42] Matched-control group Immunocompromised patients with hypoxemic ARF 19 PSV Helmet FM No difference No difference No difference Higher intolerance in FM versus helmet (47% versus 10%)
Rabitsch et al. (2003) [43] Prospective observational Immunocompromised patients with hypoxemic ARF 10 PSV Helmet - Increased 20% No data No data
Carron et al. (2010) [45] Prospective observational Hypoxemic ARF 67 PSV Helmet - Lower in NIV failure 56% Lower in NIV failure No data
Cosentini et al. (2010) [46] Randomized controlled Hypoxemic ARF 47 CPAP Helmet O2 therapy Higher in helmet No difference No difference No difference
Belenguer-Muncharaz et al. (2011) [49] Retrospective observational Hypoxemic ARF due to influenza H1N1 5 CPAP - PSV Helmet Boussignac - FM No difference 0% 100% alive No data
Squadrone et al. (2005) [53] Randomized controlled unblinded Postoperative patients with acute hypoxemia 209 CPAP Helmet O2 therapy Higher with helmet Favor helmet No difference No difference
Conti et al. (2007) [54] Matched-control Postoperative ARF 25 PSV Helmet FM No difference Favor helmet No difference Higher intolerance in FM versus helmet(32% versus 12%)
Redondo Calvo et al. (2012) [55] Prospective observational Postoperative patients with hypoxemia 99 CPAP Helmet - Increased 25% No data No data
Barbagallo et al. (2012) [56] Randomized unblinded Postoperative thoracic surgery 50 CPAP Helmet O2 therapy Higher with helmet No difference No difference No data
Antonelli et al. (2004) [57] Case-control Acute exacerbation of COPD 33 PSV Helmet FM Similar oxygenation but lower CO2 improvement with helmet No difference No difference Higher intolerance in FM versus helmet (36% versus 0%)
Antonaglia et al. (2011) [58] Randomized controlled Acute exacerbation of COPD 53 PSV Helmet FM Similar oxygenation but lower CO2 improvement with helmet Lower with helmet No difference Higher intolerance in FM versus helmet (40% versus 5%)
Navalesi et al. (2007) [59] Randomized cross-over Acute exacerbation of COPD 10 PSV Helmet FM No difference No difference No difference No difference
Vargas et al. (2009) [60] Cross-over Post-extubation ARF 11 PSV Helmet FM No data No data No data No difference
Antonelli et al. (2003) [62] Prospective observational ARF requiring FOB 4 PSV Helmet - No change No data No data No data
Rocco et al. (2010) [65] Prospective observational ARF that required NIV interruption 36 PSV Helmet FM No change 39% 28% No difference
  1. ARF, acute respiratory failure; BIPAP, bi-level positive airway pressure; CO2, carbon dioxide; COPD, chronic obstructive pulmonary disease; CPAP, continuous positive airway pressure; FM, face mask; FOB, fiberoptic bronchoscopy; NAVA, neurally adjusted ventilatory assist; O2, oxygen; PSV, pressure-support ventilation.