Publication | PMID | Study design | Setting | Patient Population | Helmet treatment | Control treatment | Intubation Rate | Mortality Rate | Main finding | Secondary findings |
---|---|---|---|---|---|---|---|---|---|---|
Antonelli et al. (2002) | 11990923 | Case control prospective study | ICU + emergency room | AHRF Helmet PSV group mean PaO2/FiO2 125 mmHg Face mask PSV group mean PaO2/FiO2 124 mmHg | Helmet PSV group (n = 33) | Face mask PSV group (n = 66) | Helmet PSV group 24% Face mask PSV group 32% | Helmet PSV group 9% Face mask PSV group 26% | Helmet NIV was as effective as face-mask NIV | Helmet improves tolerance, allows prolonged treatments and reduces complications related to skin ulcers |
Principi et al. (2003) | 14593457 | Prospective clinical study | Hematological ward | AHRF in hematological malignancy patients Helmet CPAP group mean PaO2/FiO2 135 mmHg Face mask CPAP group mean PaO2/FiO2 140 mmHg | Helmet CPAP group (n = 17) | Face mask CPAP group (n = 17) | Helmet CPAP group 0% Face mask CPAP group 41% | Helmet CPAP group 23% Face mask CPAP group 47% | Helmet CPAP was better tolerated than face mask CPAP, avoiding skin breakdown and allowing a longer period of continuous treatment with fewer ETI |  |
Rocco et al. (2004) | 15539720 | Case control study | ICU | AHRF in immunocompromised patients Helmet PSV group mean PaO2/FiO2 109 mmHg Face mask PSV group mean PaO2/FiO2 101 mmHg | Helmet PSV group (n = 19) | Face mask PSV group (n = 19) | Helmet PSV group 37% Face mask PSV group 47% | Helmet PSV group 31% Face mask PSV group 47% | Helmet NIV was as efficient as face mask NIV in avoiding ETI and improving gas exchange |  |
Cosentini et al. (2010) | 20154071 | Multicenter randomized controlled trial | Emergency department | Mild AHRF in community-acquired pneumonia Helmet CPAP group mean PaO2/FiO2 249 mmHg Standard oxygen therapy (Venturi mask) mean PaO2/FiO2 246 mmHg | Helmet CPAP group (n = 20) | Standard oxygen therapy (Venturi mask) group (n = 27) | Helmet CPAP group 0% Standard oxygen group 0% | Helmet CPAP 0% Standard oxygen 0% | CPAP delivered by helmet more efficiently improves oxygenation at 1 h |  |
Squadrone et al. (2010) | 20533022 | Single-center randomized controlled trial | Hematological ward | Prevention of ARDS in patients with hematological malignancy Helmet CPAP group mean PaO2/FiO2 441 mmHg Standard oxygen therapy (Venturi mask) mean PaO2/FiO2 392 mmHg | Helmet CPAP group (n = 20) | Standard oxygen therapy (Venturi mask) group (n = 20) | Helmet CPAP group 10% Standard oxygen therapy (Venturi mask) group 40% [95% CI 0.29–0.85] | Helmet CPAP group 15% Standard oxygen therapy (Venturi mask) group 75% | Early CPAP in immunosuppressed patients with hematological malignancy may prevent evolution to ARDS requiring ventilatory support and ICU admission |  |
Brambilla et al. (2014) | 24817030 | Multicenter randomized controlled trial | High dependency Units | AHRF Helmet CPAP group mean PaO2/FiO2 134 mmHg Standard oxygen therapy (Venturi mask) group mean PaO2/FiO2 148 mmHg | Helmet CPAP group (n = 40) | Standard oxygen therapy (Venturi mask) group (n = 41) | Met prespecified ETI criteria: Helmet CPAP group 15% Standard oxygen therapy (Venturi mask) group 63% [95% CI 0.11–0.51] ETI: Helmet CPAP group 5% Standard oxygen therapy (Venturi mask) group 2% | Helmet CPAP group 5% Standard oxygen therapy (Venturi mask) group 17% | Helmet CPAP reduces the risk of exhibiting objective criteria leading to endotracheal intubation | Helmet CPAP group yielded faster improvement in PaO2/FiO2 ratio, respiratory rate and respiratory distress |
Patel et al. (2016) | 27179847 | Single-center randomized clinical trial | ICU | ARDS Face mask NIV mean PaO2/FiO2 144 mmHg Helmet NIV mean PaO2/FiO2 118 mmHg | Helmet NIV group (n = 44) PEEP 8 cmH2O (5.0–10.0) Pressure support 8 cmH2O (5.6–10.0) | Face mask NIV group (n = 39) PEEP 5.1 cmH2O (5.0–8.0) Pressure support 11.2 cm H2O (10.0–14.5) | Face mask NIV group 62% Helmet NIV group 18% [95% CI − 62 to − 24] | Face mask NIV group = 56% Helmet NIV group = 34% [95% CI − 43 to − 1] | Helmet NIV was associated with a reduction of intubation rates compared to delivery by face mask | Helmet NIV reduces 90-day mortality and ICU length of stay |
Liu et al. (2020) | 33293689 | Single-center randomized controlled trial | ICU | AHRF in chest trauma Helmet NIV group mean PaO2/FiO2 163 mmHg Face mask NIV group mean PaO2/FiO2 162 mmHg | Helmet NIV group (n = 29) | Face mask NIV group (n = 30) | Helmet NIV group 3% Face mask NIV group 10% | Helmet NIV group 3% Face mask NIV group 3% | Helmet NIV decreased complications related to NIV, increased PaO2/FiO2 and improved tolerance compared with face mask NIV |  |
Gaulton et al. (2020) | 32984836 | Retrospective multicenter study | ICU | COVID-19 AHRF in patients with mean BMI kg/m2 = 35.5 SpO2 < 92% with 6 L/min nasal cannula | Helmet CPAP group (n = 17) | HFNO group (n = 42) | ETI within 7 days of treatment: Helmet CPAP group 18% HFNO group 52% | Death at 7 days: Helmet CPAP group 6% HFNO group 19% | Adjusting for age, helmet CPAP was associated with a decreased odds of intubation | In obese patients Helmet CPAP is effective in reducing the ETI rate |
Grieco et al. (2021) | 33764378 | Randomized multicenter clinical trial | ICU | COVID-19 AHRF Helmet NIV mean PaO2/FiO2 105 mmHg HFNO mean PaO2/FiO2 102 mmHg | Helmet NIV group (n = 54) Continuous treatment PEEP 12 (10—12) Pressure Support 10 (10–12) | HFNO group (n = 55) | Helmet NIV 30% [95% CI 19–43] HFNO 51% [95% CI 38–64] | Helmet NIV = 24% [95% CI 15–37] HFNO = 25% [16 to 38] | Helmet NIV + HFNO or HFNO alone do not affect respiratory support free days | Helmet NIV reduces rate of ETI and increases invasive VFD at day 28 |
Rezoagli et al. (2021) | 34,091,270 | Single-center observational retrospective study | ICU | AHRF Mean PaO2/FiO2 of all patients 157 mmHg | Helmet CPAP group (n = 51) | Face mask NIV group (n = 18) | Helmet CPAP 29% Face mask NIV 53% [95%CI] | ICU mortality: NIV success 1% NIV failure 22% | The use of Helmet CPAP compared to face mask NIV was an independent predictor of noninvasive respiratory support success | A positive fluid balance was independently associated with a significant increase of intubation |
Colaianni-Alfonso et al. (2022) | 36049548 | Prospective cohort study | ICU | COVID-19 AHRF Helmet CPAP mean PaO2/FiO2 96 mmHg Face mask CPAP mean PaO2/FiO2 101 mmHg | Helmet CPAP group (n = 55) | Face mask CPAP group (n = 57) | Helmet CPAP 29% Face mask CPAP 59% [95%CI] | In-hospital mortality: Helmet CPAP = 18% [95% CI] Face mask CPAP = 25% [95% CI] | Helmet CPAP compared to Facemask CPAP reduces the endotracheal intubation rate among COVID-19 patients | The use of Helmet CPAP compared to Facemask CPAP reduces the in-hospital mortality rate among COVID-19 patients |