HENIVOT Trial Study Summary

Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation, highlighted a recent study entitled 'HENIVOT Trial'. The research findings have been put forth in JAMA.

High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19. Helmet noninvasive ventilation has recently been advocated as an alternative for management of acute hypoxemic respiratory failure, but its use is limited by the lack of evidence regarding its efficacy. Putative benefits of this technique include the possibility to deliver longer-term treatments with higher levels of positive end-expiratory pressure, which may be crucial to improve hypoxemia and prevent progression of lung injury during spontaneous breathing.

Researchers undertook the current study to assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone.

The study was designed as a multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200).

Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H₂O; pressure support, 10-12 cm H₂O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55). The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included:

• The proportion of patients who required endotracheal intubation within 28 days from study enrollment
• The number of days free of invasive mechanical ventilation at day 28
• The number of days free of invasive mechanical ventilation at day 60
• In-ICU mortality
• In-hospital mortality
• 28-day mortality
• 60-day mortality
• ICU length of stay
• Hospital length of stay

Data analysis revealed some interesting facts.

Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, −2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference.

The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, −21% [95% CI, −38% to −3%]; P = .03).

The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04).

The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, −1% [95% CI, −17% to 15%]; P > .99).

For full article follow the link: doi:10.1001/jama.2021.4682

Primary source: JAMA