دورية أكاديمية

Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial.

التفاصيل البيبلوغرافية
العنوان: Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial.
المؤلفون: Michi T; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Mattana C; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Menga LS; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Bocci MG; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Cesarano M; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Rosà T; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Gualano MR; Department of Hygiene and Public Health, UniCamillus University, Rome, Italy.; Leadership in Medicine Research Center, Catholic University of The Sacred Heart, Rome , Italy., Montomoli J; Department of Anaesthesia and Intensive Care, Infermi Hospital, Rimini, Italy., Spadaro S; Department of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, University of Ferrara, Ferrara, Italy., Tosato M; Geriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Rota E; Geriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Landi F; Geriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Cutuli SL; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Tanzarella ES; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Pintaudi G; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Piervincenzi E; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Bello G; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Tonetti T; Department of Medical and Surgical Sciences, Anesthesia and Intensive Care Medicine, Alma Mater Studiorum, Policlinico Di Sant'Orsola, Università Di Bologna, Bologna, Italy., Rucci P; Department of Biomedical and Neuromotor Science, Alma Mater Studiorum-Università Di Bologna, Bologna, Italy., De Pascale G; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Maggiore SM; Department of Anesthesiology, Critical Care Medicine and Emergency, SS. Annunziata Hospital, Chieti, Italy., Grieco DL; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy. dlgrieco@outlook.it.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy. dlgrieco@outlook.it., Conti G; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy., Antonelli M; Department of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. Vito, 00168, Rome, Italy.; Istituto Di Anestesiologia E Rianimazione, Catholic University of The Sacred Heart, Rome, Italy.
مؤلفون مشاركون: Gemelli COVID-ICU study group
المصدر: Journal of intensive care [J Intensive Care] 2023 May 19; Vol. 11 (1), pp. 21. Date of Electronic Publication: 2023 May 19.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101627304 Publication Model: Electronic Cited Medium: Print ISSN: 2052-0492 (Print) Linking ISSN: 20520492 NLM ISO Abbreviation: J Intensive Care Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, 2013-
مستخلص: Background: Long-term outcomes of patients treated with helmet noninvasive ventilation (NIV) are unknown: safety concerns regarding the risk of patient self-inflicted lung injury and delayed intubation exist when NIV is applied in hypoxemic patients. We assessed the 6-month outcome of patients who received helmet NIV or high-flow nasal oxygen for COVID-19 hypoxemic respiratory failure.
Methods: In this prespecified analysis of a randomized trial of helmet NIV versus high-flow nasal oxygen (HENIVOT), clinical status, physical performance (6-min-walking-test and 30-s chair stand test), respiratory function and quality of life (EuroQoL five dimensions five levels questionnaire, EuroQoL VAS, SF36 and Post-Traumatic Stress Disorder Checklist for the DSM) were evaluated 6 months after the enrollment.
Results: Among 80 patients who were alive, 71 (89%) completed the follow-up: 35 had received helmet NIV, 36 high-flow oxygen. There was no inter-group difference in any item concerning vital signs (N = 4), physical performance (N = 18), respiratory function (N = 27), quality of life (N = 21) and laboratory tests (N = 15). Arthralgia was significantly lower in the helmet group (16% vs. 55%, p = 0.002). Fifty-two percent of patients in helmet group vs. 63% of patients in high-flow group had diffusing capacity of the lungs for carbon monoxide < 80% of predicted (p = 0.44); 13% vs. 22% had forced vital capacity < 80% of predicted (p = 0.51). Both groups reported similar degree of pain (p = 0.81) and anxiety (p = 0.81) at the EQ-5D-5L test; the EQ-VAS score was similar in the two groups (p = 0.27). Compared to patients who successfully avoided invasive mechanical ventilation (54/71, 76%), intubated patients (17/71, 24%) had significantly worse pulmonary function (median diffusing capacity of the lungs for carbon monoxide 66% [Interquartile range: 47-77] of predicted vs. 80% [71-88], p = 0.005) and decreased quality of life (EQ-VAS: 70 [53-70] vs. 80 [70-83], p = 0.01).
Conclusions: In patients with COVID-19 hypoxemic respiratory failure, treatment with helmet NIV or high-flow oxygen yielded similar quality of life and functional outcome at 6 months. The need for invasive mechanical ventilation was associated with worse outcomes. These data indicate that helmet NIV, as applied in the HENIVOT trial, can be safely used in hypoxemic patients. Trial registration Registered on clinicaltrials.gov NCT04502576 on August 6, 2020.
(© 2023. The Author(s).)
References: Expert Rev Respir Med. 2023 Jan;17(1):27-39. (PMID: 36710082)
Arch Bronconeumol. 2022 Feb;58(2):142-149. (PMID: 34497426)
JAMA. 2021 May 4;325(17):1731-1743. (PMID: 33764378)
Crit Care Med. 2002 Mar;30(3):602-8. (PMID: 11990923)
Curr Opin Crit Care. 2020 Feb;26(1):59-65. (PMID: 31815775)
Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. (PMID: 12091180)
JAMA. 2020 Aug 11;324(6):603-605. (PMID: 32644129)
Crit Care Med. 2018 Jul;46(7):1078-1084. (PMID: 29595563)
Lancet Respir Med. 2021 Jul;9(7):747-754. (PMID: 33964245)
Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. (PMID: 27626833)
Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. (PMID: 27786562)
Am J Respir Crit Care Med. 2021 Sep 15;204(6):725-728. (PMID: 34214009)
Crit Care Med. 2012 May;40(5):1578-85. (PMID: 22430241)
J Clin Med. 2021 Jun 21;10(12):. (PMID: 34205783)
ERJ Open Res. 2022 Oct 24;8(4):. (PMID: 36284829)
JAMA. 2020 Apr 28;323(16):1574-1581. (PMID: 32250385)
Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211009410. (PMID: 33878961)
Minerva Anestesiol. 2019 Sep;85(9):1014-1023. (PMID: 30871304)
Viruses. 2021 Apr 18;13(4):. (PMID: 33919537)
Intensive Care Med. 2021 Aug;47(8):851-866. (PMID: 34232336)
Respir Med. 2021 Jun;182:106394. (PMID: 33901787)
J Clin Epidemiol. 1998 Nov;51(11):1025-36. (PMID: 9817120)
Am J Respir Crit Care Med. 2022 Feb 1;205(3):360-364. (PMID: 34788583)
Lancet Respir Med. 2020 Aug;8(8):807-815. (PMID: 32422178)
JAMA. 2016 Feb 23;315(8):788-800. (PMID: 26903337)
Crit Care Med. 2016 Aug;44(8):e678-88. (PMID: 27002273)
Respir Res. 2022 May 4;23(1):115. (PMID: 35509060)
Am J Respir Crit Care Med. 2020 Feb 1;201(3):303-312. (PMID: 31687831)
Eur Respir J. 2022 Mar 10;59(3):. (PMID: 34413155)
Lancet. 2021 Jan 16;397(10270):220-232. (PMID: 33428867)
Eur Respir J. 2021 Jul 22;58(1):. (PMID: 33574077)
JAMA. 2016 Jun 14;315(22):2435-41. (PMID: 27179847)
JAMA. 2021 Apr 20;325(15):1525-1534. (PMID: 33729425)
Respiration. 2021;100(11):1078-1087. (PMID: 34515212)
J Med Virol. 2022 Jan;94(1):253-262. (PMID: 34463956)
Biomedicines. 2021 Jul 27;9(8):. (PMID: 34440104)
PLoS One. 2021 Apr 15;16(4):e0250063. (PMID: 33857228)
Clin Infect Dis. 2021 Sep 7;73(5):e1089-e1098. (PMID: 33220049)
Lancet Respir Med. 2022 Sep;10(9):863-876. (PMID: 35568052)
JAMA Netw Open. 2021 Jan 4;4(1):e2036142. (PMID: 33502487)
Ann Intensive Care. 2022 Feb 20;12(1):16. (PMID: 35184214)
N Engl J Med. 2011 Apr 7;364(14):1293-304. (PMID: 21470008)
Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. (PMID: 29323536)
BMC Geriatr. 2017 Dec 7;17(1):281. (PMID: 29216838)
Crit Care. 2016 Aug 23;20:265. (PMID: 27549178)
Intensive Care Med. 2023 Mar;49(3):302-312. (PMID: 36820878)
Am J Respir Crit Care Med. 2017 Jan 1;195(1):67-77. (PMID: 27753501)
Med Care. 1992 Jun;30(6):473-83. (PMID: 1593914)
Ann Intensive Care. 2022 Oct 14;12(1):94. (PMID: 36241926)
JAMA. 2020 Jul 7;324(1):57-67. (PMID: 32496521)
Respir Care. 2018 Jan;63(1):77-85. (PMID: 28874609)
Eur Respir J. 2022 Apr 14;59(4):. (PMID: 34649974)
Am J Respir Crit Care Med. 2023 May 15;207(10):1310-1323. (PMID: 36378814)
BMC Pulm Med. 2021 Mar 22;21(1):97. (PMID: 33752639)
Eur Respir J. 2017 Aug 31;50(2):. (PMID: 28860265)
Eur Respir J. 2021 Sep 16;58(3):. (PMID: 33574080)
N Engl J Med. 2003 Feb 20;348(8):683-93. (PMID: 12594312)
Chest. 2021 Jul;160(1):187-198. (PMID: 33676998)
BMJ. 2021 Jul 26;374:n1648. (PMID: 34312178)
Clin Infect Dis. 2022 Jan 29;74(2):301-308. (PMID: 33893486)
Expert Rev Respir Med. 2021 Jun;15(6):791-803. (PMID: 33902377)
Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. (PMID: 24199628)
معلومات مُعتمدة: 2017 MSD award SIAARTI
فهرسة مساهمة: Investigator: R Maviglia; G Mercurio; P De Santis; MA Pennisi; GM Anzellotti; F Torrini; C Rubino; TC Morena; V Gennenzi; S Postorino; J Vargas; N Filetici; D Settanni; M Durante; L Cascarano; M Di Muro; R Scarascia; MM Bitondo; M Murdolo; A Mele; S Silva; C Zaccone; F Pozzana; A Maccaglia; M Savino; A Potalivo; F Ceccaroni; A Scavone; G Lombardi; G Bello; L Montini; AM Dell'Anna; CA Volta; VM Ranieri; G Falò; S Carelli; D Natalini; C Berardi; L Delle Cese; L Vetrugno; E Balzani
Keywords: Acute respiratory failure; COVID-19; Helmet; High-flow nasal oxygen; Noninvasive ventilation; Patient self-inflicted lung injury (P-SILI)
سلسلة جزيئية: ClinicalTrials.gov NCT04502576
تواريخ الأحداث: Date Created: 20230519 Latest Revision: 20230522
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC10195662
DOI: 10.1186/s40560-023-00669-0
PMID: 37208787
قاعدة البيانات: MEDLINE
الوصف
تدمد:2052-0492
DOI:10.1186/s40560-023-00669-0