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

被引：288

作者：

Grieco, Domenico Luca ^{[1
,2
]}

Menga, Luca S. ^{[1
,2
]}

Cesarano, Melania ^{[1
,2
]}

Rosa, Tommaso ^{[2
]}

Spadaro, Savino ^{[3
]}

Bitondo, Maria Maddalena ^{[4
]}

Montomoli, Jonathan ^{[4
]}

Falo, Giulia ^{[3
]}

Tonetti, Tommaso ^{[5
]}

Cutuli, Salvatore L. ^{[1
,2
]}

Pintaudi, Gabriele ^{[1
,2
]}

Tanzarella, Eloisa S. ^{[1
,2
]}

Piervincenzi, Edoardo ^{[1
,2
]}

Bongiovanni, Filippo ^{[1
,2
]}

Dell'Anna, Antonio M. ^{[1
,2
]}

Delle Cese, Luca ^{[1
,2
]}

Berardi, Cecilia ^{[1
,2
]}

Carelli, Simone ^{[1
,2
]}

Bocci, Maria Grazia ^{[1
,2
]}

Montini, Luca ^{[1
,2
]}

Bello, Giuseppe ^{[1
,2
]}

Natalini, Daniele ^{[1
,2
]}

De Pascale, Gennaro ^{[1
,2
]}

Velardo, Matteo ^{[6
]}

Volta, Carlo Alberto ^{[3
]}

Ranieri, V. Marco ^{[5
]}

Conti, Giorgio ^{[1
,2
]}

Maggiore, Salvatore Maurizio ^{[7
,8
]}

Antonelli, Massimo ^{[1
,2
]}

机构：

[1] Fdn Policlin Univ AGemelli IRCCS, Dept Emergency Intens Care Med & Anesthesia, Rome, Italy

[2] Univ Cattolica Sacro Cuore, Ist Anestesiol & Rianimaz, Rome, Italy

[3] Univ Ferrara, Dept Morphol Surg & Expt Med, Azienda Osped Univ Arcispedale St Anna, Ferrara, Italy

[4] Infermi Hosp, Dept Anaesthesia & Intens Care, Rimini, Italy

[5] Alma Mater Studiorum Univ Bologna, Policlin St Orsola, Dipartimento Sci Med & Chirurg, Anesthesia & Intens Care Med, Bologna, Italy

[6] EESOA Simulat Ctr, European Sch Obstet Anesthesia, Rome, Italy

[7] Gabriele dAnnunzio Univ Chieti Pescara, Univ Dept Innovat Technol Med & Dent, Chieti, Italy

[8] SS Annunziata Hosp, Dept Anesthesiol Crit Care Med & Emergency, Chieti, Italy

来源：

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2021年 / 325卷 / 17期

关键词：

POSITIVE-PRESSURE VENTILATION; INFLICTED LUNG INJURY; MECHANICAL VENTILATION; IMPACT;

D O I：

10.1001/jama.2021.4682

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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]; 21women [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% to15%]; 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.

引用

页码：1731 / 1743

页数：13