Corresponding Author: Domenico L. Grieco, MD, Department of Anesthesiology and Intensive Care Medicine, Catholic University of the Sacred Heart, Fondazione Policlinico Universitario A. Gemelli IRCCS, Lgo F Vito, 00168, Rome, Italy (dlgrieco@outlook.it).
Accepted for Publication: March 12, 2021.
Published Online: March 25, 2021. doi:10.1001/jama.2021.4682
Author Contributions: Drs Grieco and Menga had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Grieco, Pintaudi, Dell'Anna, Bocci, De Pascale, Volta, Conti, Maggiore, Antonelli.
Acquisition, analysis, or interpretation of data: Grieco, Menga, Cesarano, Rosà, Spadaro, Bitondo, Montomoli, Falò, Tonetti, Cutuli, Pintaudi, Tanzarella, Piervincenzi, Bongiovanni, Dell’Anna, Delle Cese, Berardi, Carelli, Montini, Bello, Natalini, De Pascale, Velardo, Volta, Ranieri, Antonelli.
Drafting of the manuscript: Grieco, Menga, Cesarano, Pintaudi, Bongiovanni, Dell’Anna, Carelli, Bocci, Natalini, De Pascale, Antonelli.
Critical revision of the manuscript for important intellectual content: Grieco, Menga, Rosà, Spadaro, Bitondo, Montomoli, Falò, Tonetti, Cutuli, Pintaudi, Tanzarella, Piervincenzi, Bongiovanni, Delle Cese, Berardi, Montini, Bello, De Pascale, Velardo, Volta, Ranieri, Conti, Maggiore, Antonelli.
Statistical analysis: Grieco, Montini, De Pascale, Velardo.
Obtained funding: Grieco, Antonelli.
Administrative, technical, or material support: Grieco, Cesarano, Rosà, Spadaro, Bitondo, Pintaudi, Tanzarella, Piervincenzi, Bongiovanni, Dell’Anna, Bocci, Natalini, De Pascale, Antonelli.
Supervision: Grieco, Spadaro, Pintaudi, Piervincenzi, Bongiovanni, Dell’Anna, Bocci, Bello, De Pascale, Volta, Ranieri, Conti, Maggiore, Antonelli.
Conflict of Interest Disclosures: Dr Grieco reported receiving grants from the Italian Society of Anesthesia, Analgesia, and Intensive Care Medicine during the conduct of the study and grants from the European Society of Intensive Care Medicine and GE Healthcare and travel expenses from Maquet, Getinge, and Air Liquide outside the submitted work. Dr Montomoli reported receiving personal fees from Active Medica BV outside the submitted work. Dr Conti reported receiving payments for lectures from Chiesi Pharmaceuticals SpA. Dr Maggiore reported serving as the principal investigator of the RINO trial (ClinicalTrials.gov NCT02107183), which was supported by Fisher and Paykel Healthcare through an institutional grant, and receiving personal fees from Draeger Medical and GE Healthcare outside the submitted work. Dr Antonelli reported receiving personal fees from Maquet, Chiesi, and Air Liquide and grants from GE Healthcare outside the submitted work. No other disclosures were reported.
Funding/Support: The study was funded by a research grant (2017 Merck Sharp & Dohme SRL award) by the Italian Society of Anesthesia, Analgesia, and Intensive Care Medicine.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The COVID-ICU Gemelli Study Group members are listed in Supplement 4.
Data Sharing Statement: See Supplement 5.
Additional Contributions: We are grateful to all intensive care unit physicians, residents, nurses, and personnel from the participating centers, whose sacrifice, efforts, devotion to patients, and passion have made possible this timely report. We are grateful to Jean-Pierre Frat, MD, PhD (Poitiers, France), Oriol Roca, MD, PhD (Barcelona, Spain), and Jordi Mancebo, MD, PhD (Barcelona, Spain), for their contribution as members of the adjudication committee for endotracheal intubation. We are grateful to Cristina Cacciagrano, Emiliano Tizi, and Alberto Noto, MD, for their contribution to study organization. We are grateful to Gabriele Esposito, PD, for Figure 1 drafting. Drs Frat, Roca, and Velardo received a personal fee for their contribution to the study; all others listed did not receive compensation.
Additional Information: The study was endorsed by the Insufficienza Respiratoria Acuta e Assistenza Respiratoria study group of the Italian Society of Anesthesia, Analgesia, and Intensive Care Medicine.
2.Yoshida
T , Fujino
Y , Amato
MBP , Kavanagh
BP . Fifty years of research in ARDS: spontaneous breathing during mechanical ventilation: risks, mechanisms, and management.
Am J Respir Crit Care Med. 2017;195(8):985-992. doi:
10.1164/rccm.201604-0748CPPubMedGoogle ScholarCrossref 4.Bellani
G , Laffey
JG , Pham
T ,
et al; LUNG SAFE Investigators; ESICM Trials Group. Noninvasive ventilation of patients with acute respiratory distress syndrome: insights from the LUNG SAFE Study.
Am J Respir Crit Care Med. 2017;195(1):67-77. doi:
10.1164/rccm.201606-1306OC
PubMedGoogle ScholarCrossref 5.Franco
C , Facciolongo
N , Tonelli
R ,
et al. Feasibility and clinical impact of out-of-ICU noninvasive respiratory support in patients with COVID-19-related pneumonia.
Eur Respir J. 2020;56(5):2002130. doi:
10.1183/13993003.02130-2020
PubMedGoogle Scholar 6.Grasselli
G , Zangrillo
A , Zanella
A ,
et al; COVID-19 Lombardy ICU Network. Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region, Italy.
JAMA. 2020;323(16):1574-1581. doi:
10.1001/jama.2020.5394
PubMedGoogle ScholarCrossref 7.COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study.
Intensive Care Med. 2021;47(1):60-73. doi:
10.1007/s00134-020-06294-x
PubMedGoogle ScholarCrossref 10.Patel
BK , Wolfe
KS , Pohlman
AS , Hall
JB , Kress
JP . Effect of noninvasive ventilation delivered by helmet vs face mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome: a randomized clinical trial.
JAMA. 2016;315(22):2435-2441. doi:
10.1001/jama.2016.6338
PubMedGoogle ScholarCrossref 11.Ferreyro
BL , Angriman
F , Munshi
L ,
et al. Association of noninvasive oxygenation strategies with all-cause mortality in adults with acute hypoxemic respiratory failure: a systematic review and meta-analysis.
JAMA. 2020;324(1):57-67. doi:
10.1001/jama.2020.9524
PubMedGoogle ScholarCrossref 16.Grieco
DL , Toni
F , Santantonio
MT ,
et al. Comfort during high-flow oxygen therapy through nasal cannula in critically ill patients: effects of gas temperature and flow. Presented at the 26th Annual Congress of the European Society of Intensive Medicine; October 5-9, 2013; Paris, France.
17.Muriel
A , Peñuelas
O , Frutos-Vivar
F ,
et al. Impact of sedation and analgesia during noninvasive positive pressure ventilation on outcome: a marginal structural model causal analysis.
Intensive Care Med. 2015;41(9):1586-1600. doi:
10.1007/s00134-015-3854-6
PubMedGoogle ScholarCrossref 18.Coppo
A , Bellani
G , Winterton
D ,
et al. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study.
Lancet Respir Med. 2020;8(8):765-774. doi:
10.1016/S2213-2600(20)30268-X
PubMedGoogle ScholarCrossref 21.Fan
E , Del Sorbo
L , Goligher
EC ,
et al; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine clinical practice guideline: mechanical ventilation in adult patients with acute respiratory distress syndrome.
Am J Respir Crit Care Med. 2017;195(9):1253-1263. doi:
10.1164/rccm.201703-0548ST
PubMedGoogle ScholarCrossref 23.Maggiore
SM , Idone
FA , Vaschetto
R ,
et al. Nasal high-flow versus Venturi mask oxygen therapy after extubation: effects on oxygenation, comfort, and clinical outcome.
Am J Respir Crit Care Med. 2014;190(3):282-288. doi:
10.1164/rccm.201402-0364OC
PubMedGoogle ScholarCrossref 24.Menga
LS , Cese
LD , Bongiovanni
F ,
et al. High failure rate of noninvasive oxygenation strategies in critically ill subjects with acute hypoxemic respiratory failure due to COVID-19.
Respir Care. 2021;(March):respcare.08622. doi:
10.4187/respcare.08622
PubMedGoogle Scholar 27.Ferrer
M , Esquinas
A , Leon
M , Gonzalez
G , Alarcon
A , Torres
A . Noninvasive ventilation in severe hypoxemic respiratory failure: a randomized clinical trial.
Am J Respir Crit Care Med. 2003;168(12):1438-1444. doi:
10.1164/rccm.200301-072OC
PubMedGoogle ScholarCrossref 28.Demoule
A , Chevret
S , Carlucci
A ,
et al; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries.
Intensive Care Med. 2016;42(1):82-92. doi:
10.1007/s00134-015-4087-4
PubMedGoogle ScholarCrossref 33.Tonelli
R , Fantini
R , Tabbì
L ,
et al. Early inspiratory effort assessment by esophageal manometry predicts noninvasive ventilation outcome in
de novo respiratory failure: a pilot study.
Am J Respir Crit Care Med. 2020;202(4):558-567. doi:
10.1164/rccm.201912-2512OC
PubMedGoogle ScholarCrossref 37.Zucman
N , Mullaert
J , Roux
D , Roca
O , Ricard
J-D ; Contributors. Prediction of outcome of nasal high flow use during COVID-19–related acute hypoxemic respiratory failure.
Intensive Care Med. 2020;46(10):1924-1926. doi:
10.1007/s00134-020-06177-1
PubMedGoogle ScholarCrossref