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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.