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April - 2021

   

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Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure The HENIVOT Randomized Clinical Trial

D Grieco, L Menga, M Cesarano, et al for the COVID-ICU Gemelli Study Group JAMA, 2021, March 2021

Comment

The HENIVOT set out to compare the effect of early continuous treatment with helmet noninvasive ventilation to high-flow nasal oxygen, on the number of days free of respiratory support at 28 days, in adult patients admitted to ICU with COVID-19–induced moderate to severe hypoxemic respiratory failure. 

Why? The uncertainty about initial and noninvasive ventilatory management of hypoxemic respiratory failure in COVID-19, has led to different approaches This included renewed interest in helmet NIV, with its potential benefit of improved tolerance for longer term treatment. The HENIVOT trial set out assess this treatment modality.

What did they do?

  • Randomised 109 of 182 adult patients in 4 Italian ICUs, who due to pandemic all had confirmed diagnosis COVID-19 
  • Moderate to severed hypoxemic resp failure within 24 hrs of ICU admission (PF 
  • Open label randomised 1:1 to;
    • HFNC: 60 l/m, titrated down, aim SpO2 92-98%, allowed to wean after 48 hrs if FiO2 
    • Helmet: 48hrs continuous helmet NIV, set at PSV initially 10-12 cm H2O, adjusted to PIF 100 L/m, PEEP 10-12 cmH2O, FiO2 titrated SpO2 92-98%. After 48 hrs attempted to wean as for HFNC
  • Treatment failure was defined as need for endotracheal intubation, based on predefined criteria. This included at least 2 of the following: worsening or unchanged unbearable dyspnea; lack of improvement in oxygenation and/or SpO2 below 90% for > 5 minutes without technical dysfunction; lack of improvement of signs of respiratory-muscle fatigue; development of unmanageable tracheal secretions; respiratory acidosis with a pH < 7.30 despite face mask noninvasive ventilation; and intolerance to the used device. Also if developed hemodynamic instability (SBP 

What did they find?

  • Treatments: 
    • Helmet: 91% received 48 hrs of continuous treatment, with a mean PEEP 12 cmH20 + PS 10cmH2O. 
    • HFNC: 87% received 48 hrs of continuous treatment, 
  • Primary outcome was median number of days free of respiratory support within 28 days: 20 days in helmet group vs 18 days in HFNC group, not statistically significant (p=0.26)
  • Secondary outcomes: Of 9 prespecififed, 7 showed no significance. 
    • 44 required intubation within 28-days, and this was lower in helmet group (30%) vs HFNC (51%), abs risk reduction 21% (95% CI 3-38%), unadjusted OR 0.41 (95% CI 0.18, 0.89, p=0.03)
    • Median days free of invasive ventilation within 28-days were 28 (helmet) vs 25 (HFNC) (abs diff 3-days, 95% CI 0-7, p=0.04)
  • Exploratory end points: Over initial 48 hrs helmet group has improved oxygenation and dyspnea, but worse device discomfort.  

Summary: Among critically ill patients with moderate to severe hypoxemic respiratory failure due to COVID-19, 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. There was a difference in the use of invasive ventilation during those 28-days, with lower use in the helmet group. This could be viewed as helmet NIV not altering disease course, but reducing the use of invasive ventilation as component of respiratory support in 1st 28-days.

 

Abstract

 

Importance  High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19.

Objective  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.

Design, Setting, and Participants  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).

Interventions  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).

Main Outcomes and Measures  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, and hospital length of stay.

Results  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).

Conclusions and Relevance  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.

April


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