Table 2.
Comparative studies regarding helmet support
| 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 |
FiO2 fraction of inspired oxygen, PaO2 partial pressure of arterial oxygen, SpO2 peripheral capillary oxygen saturation, HFNO high-flow nasal oxygen, NIV non-invasive ventilation, CPAP continuous positive end-expiratory pressure, AHRF acute hypoxemic respiratory failure, ARDS acute respiratory distress syndrome, ETI endotracheal intubation, BMI Body Mass Index, ICU intensive care unit