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Table 2 Comparative studies regarding helmet support

From: Helmet noninvasive support for acute hypoxemic respiratory failure: rationale, mechanism of action and bedside application

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

  1. 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