Fração de oxigênio inspirado ou alvos de oxigenação arterial maiores versus menores para adultos internados na unidade de terapia intensiva: uma Revisão Cochrane
Resumo
Introdução: A oxigenioterapia é a principal intervenção para a hipoxemia. A grande maioria dos adultos internados na UTI recebe oxigenioterapia. A prática de administrar oxigênio tem sido liberal, o que pode resultar em hiperoxemia. Alguns estudos, mas não todos, relataram uma possível associação entre hiperoxemia e aumento do risco de morte. Não se sabe qual é o alvo ideal para o oxigênio suplementar oferecido para os adultos internados na UTI. Apesar da ausência de evidência robusta de efetividade, a administração de oxigênio é amplamente recomendada nas diretrizes internacionais de prática clínica. O benefício potencial do oxigênio suplementar deve ser pesado contra os efeitos potencialmente nocivos da hiperoxemia.
Objetivos: Avaliar os benefícios e danos de usar fração de oxigênio inspirado ou alvos de oxigenação arterial maiores versus menores para adultos internados na UTI.
Métodos de busca: Fizemos buscas por ensaios clínicos randomizados nas seguintes bases de dados: CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, BIOSIS Previews, CINAHL, e LILACS. Buscamos por estudos não publicados ou em andamento em plataformas de registro de ensaios clínicos. Também revisamos as listas de referências dos estudos incluídos. As buscas foram realizadas em dezembro de 2018.
Critério de seleção: Incluímos ensaios clínicos randomizados (ECRs) que compararam fração maior versus fração menor de oxigênio inspirado ou alvos de oxigenação arterial maior versus menor para adultos internados na UTI. Não houve restrições de idiomas ou por tipo ou status de publicação.
Incluímos na revisão ECRs com uma diferença entre os grupos intervenção e controle de, no mínimo: 1) 1 kPa na pressão parcial de oxigênio arterial (PaO2); 2) 10% na fração inspirada de oxigênio (FiO2); ou 3) 2% na saturação de oxigênio arterial de hemoglobina/saturação de oxigênio periférica não‐invasiva (SaO2/SpO2).
Excluímos os ensaios clínicos que randomizaram participantes para hipoxemia (FiO2 abaixo de 0,21, SaO2/SpO2 abaixo de 80% e PaO2 abaixo de 6 kPa) e para oxigênio hiperbárico.
Coleta dos dados e análises: Três autores da revisão, trabalhando de forma independente em pares, selecionaram as referências recuperadas nas buscas bibliográficas e extraíram os dados. Os desfechos primários foram a mortalidade por todas as causas, a proporção de participantes com um ou mais eventos adversos graves e a qualidade de vida. Nenhum dos ECRs avaliou a proporção de participantes com um ou mais eventos adversos graves de acordo com os critérios da Conferência Internacional sobre Harmonização de Boas Práticas Clínicas (ICH‐GCP). No entanto, a maioria dos estudos relatou vários eventos adversos graves. Portanto, incluímos a proporção de participantes com um evento adverso grave em cada estudo nas análises do efeito de usar fração inspirada de oxigênio ou alvos de oxigenação maior versus menor. Os desfechos secundários foram lesão pulmonar, infarto agudo do miocárdio, acidente vascular encefálico e sepse.
Nenhum dos estudos avaliou lesão pulmonar como desfecho composto. Porém alguns estudos avaliaram síndrome da angústia respiratória aguda (SDRA) e pneumonia. Fizemos uma análise do efeito de usar fração inspirada de oxigênio ou alvos maiores versus menores usando a maior proporção relatada de participantes com SDRA ou pneumonia em cada estudo. Avaliamos o risco de viés de cada estudo para identificar o risco de erros sistemáticos. Usamos o GRADE para avaliar a qualidade (certeza) geral da evidência.
Principais resultados: Incluímos 10 ECRs (1458 participantes), sete dos quais relataram desfechos relevantes para esta revisão (1285 participantes). Todos os estudos tinham, no geral, um alto risco de viés. Dois estudos tinham baixo risco de viés para todos os domínios exceto para o cegamento de participantes e profissionais.
O uso de fração inspirada de oxigênio ou alvos de oxigenação arterial mais altos, em comparação à fração ou alvos mais baixos, aumenta a mortalidade avaliada cerca de três meses após: risco relativo (RR) 1,18, intervalo de confiança (IC) de 95% 1,01 a 1,37, I2 = 0%, 4 estudos, 1135 participantes, evidência de qualidade muito baixa. O uso de fração inspirada de oxigênio ou alvos de oxigenação arterial mais altos, em comparação à fração ou alvos mais baixos, aumenta o risco de eventos adversos graves avaliados cerca de três meses após: maior proporção estimada de eventos adversos específicos em cada estudo RR 1,13, IC 95% 1,04 a 1,23, I2 = 0%, 1234 participantes, 6 estudos, evidência de qualidade muito baixa. Estes achados devem ser interpretados com cautela uma vez que se baseiam em evidência de qualidade muito baixa.
Nenhum dos estudos incluídos avaliou qualidade de vida em qualquer momento.
Não há evidência de diferença entre o uso de maior fração inspirada de oxigênio ou alvos de oxigenação arterial mais altos, em comparação à menor fração ou alvos, na lesão pulmonar avaliada cerca de três meses após: estimativa da maior proporção relatada de lesão pulmonar RR 1,03, IC 95% 0,78 a 1,36, I2 = 0%, 5 estudos,1167 participantes, evidência de qualidade muito baixa.
Nenhum dos estudos incluídos avaliou infarto agudo do miocárdio ou acidente vascular encefálico e apenas um ensaio clínico avaliou o risco de sepse.
Conclusão dos autores: Há muita incerteza acerca dos efeitos do uso de maior fração inspirada de oxigênio ou alvos de oxigenação arterial mais altos, em comparação à fração ou alvos mais baixos, para adultos internados na UTI sobre mortalidade por todas as causas, eventos adversos graves e lesões pulmonares avaliados cerca de três meses depois. Isso se deve ao fato da qualidade da evidência ser muito baixa. Os resultados desta revisão indicam que o uso de maior fração inspirada de oxigênio ou alvos de oxigenação arterial mais altos, em comparação à fração ou alvos mais baixos, pode aumentar a mortalidade. Nenhum dos estudos relatou a proporção de participantes com um ou mais eventos adversos graves de acordo com os critérios ICH‐GCP. Porém os estudos relataram um aumento no número de eventos adversos graves com o uso de maior fração inspirada de oxigênio ou alvos de oxigenação arterial mais altos. Os efeitos sobre a qualidade de vida, infarto agudo do miocárdio, acidente vascular encefálico e sepse são desconhecidos devido à falta de dados.
Referências
References to studies included in this review:
Asfar 2017 {published data only}
Asfar P, Schortgen F, Boisramé‐Helms J, Charpentier J, Guérot E, Megarbane B, et al. Hyperoxia and hypertonic saline in patients with septic shock (HYPERS2S): a two‐by‐two factorial, multicentre, randomised, clinical trial. Lancet. Respiratory Medicine 2017;5(3):180‐90. [PUBMED: 28219612]
Girardis 2016 {published data only}
Girardis M, Busani S, Damiani E, Donati A, Rinaldi L, Marudi A, et al. Effect of conservative vs conventional oxygen therapy on mortality among patients in an intensive care unit: the oxygen‐ICU randomized clinical trial. JAMA 2016;316(15):1583‐9. [PUBMED: 27706466]
Gomersall 2002 {published data only}
Gomersall CD, Joynt GM, Freebairn RC, Lai CK, Oh TE. Oxygen therapy for hypercapnic patients with chronic obstructive pulmonary disease and acute respiratory failure: a randomized, controlled pilot study. Critical Care Medicine 2002;30(1):113‐6. [PUBMED: 11905405]
Ishii 2018 {published data only}
Ishii K, Morimatsu H, Hyodo T, Ono K, Hidaka H, Koyama Y, et al. Relationship between inspired oxygen concentration and atelectasis formation after extubation. Critical Care Medicine 2018;46(1 Suppl 1):533. [DOI: 10.1097/01.ccm.0000529104.66235.9e]
Jakkula 2018 {published data only}
Jakkula P, Reinikainen M, Hästbacka J, Loisa P, Tiainen M, Pettilä V, et al. Targeting two different levels of both arterial carbon dioxide and arterial oxygen after cardiac arrest and resuscitation: a randomised pilot trial. Intensive Care Medicine 2018;44(12):2112‐21. [PUBMED: 30430209]
Lång 2018 {published data only}
Lång M, Skrifvars MB, Siironen J, Tanskanen P, Ala‐Peijari M, Koivisto T, et al. A pilot study of hyperoxemia on neurological injury, inflammation and oxidative stress. Acta Anaesthesiologica Scandinavica 2018;62(6):801‐10. [PUBMED: 29464691]
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Panwar 2016 {published data only}
Panwar R, Hardie M, Bellomo R, Barrot L, Eastwood GM, Young PJ, et al. Conservative versus liberal oxygenation targets for mechanically ventilated patients. A pilot multicenter randomized controlled trial. American Journal of Respiratory and Critical Care Medicine 2016;193(1):43‐51. [PUBMED: 26334785]
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References to studies excluded from this review:
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Huynh Ky M, Bouchard PA, Morin J, L'Her E, Sarrazin JF, Lellouche F. Closed‐loop adjustment of oxygen flowrate with FreeO2 in patients with acute coronary syndrome: comparison of automated titration with FreeO2 (set at two SpO2 target) and of manual titration. A randomized controlled study. Annals of Intensive Care 2017;7(Suppl 1):O59.
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Khoshnood A, Carlsson M, Akbarzadeh M, Bhiladvala P, Roijer A, Nordlund D, et al. Effect of oxygen therapy on myocardial salvage in ST elevation myocardial infarction: the randomized SOCCER trial. European Journal of Emergency Medicine 2018;25(2):78‐84. [PUBMED: 27893526]
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Ranchord AM, Argyle R, Beynon R, Perrin K, Sharma V, Weatherall M, et al. High‐concentration versus titrated oxygen therapy in ST elevation myocardial infarction: a pilot randomized controlled trial. American Heart Journal 2012;163(2):168‐75. [PUBMED: 22305833]
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Roffe C, Sills S, Pountain SJ, Allen M. A randomized controlled trial of the effect of fixed‐dose routine nocturnal oxygen supplementation on oxygen saturation in patients with acute stroke. Journal of Stroke and Cerebrovascular Diseases 2010;19(1):29‐35. [PUBMED: 20123224]
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Ukholkina GB, Kostianov IIu, Kuchkina NV, Grendo EP, Gofman IaB. Effect of oxygenotherapy used in combination with reperfusion in patients with acute myocardial infarction. Kardiologiia 2005;45(5):59. [PUBMED: 16007057]
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Wu J, Nevatte T, Roffe C. The stroke oxygen supplementation (S02S) study: comparison of postal and telephone responses of 12 months questionnaire follow up. International Journal of Stroke 2014;9(Suppl 4):37.
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Young P, Bailey M, Bellomo R, Bernard S, Dicker B, Freebairn R, et al. HyperOxic Therapy OR NormOxic Therapy after out‐of‐hospital cardiac arrest (HOT OR NOT): a randomised controlled feasibility trial. Resuscitation 2014;85(12):1686‐91. [PUBMED: 25261605]
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References to studies awaiting assessment:
ICU‐ROX 2019 {published data only}
ICU‐ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group, Mackle D, Bellomo R, Bailey M, Beasley R, Deane A, Eastwood G, Finfer S, Freebairn R, King V, Linke N, Litton E, McArthur C, McGuinness S, Panwar R, Young P. Conservative Oxygen Therapy during Mechanical Ventilation in the ICU. New England Journal of Medicine 2019:[Epub ahead of print]. [PUBMED: 31613432]
References to ongoing studies:
NCT02321072 {published data only}
NCT02321072. Optimal oxygenation in the intensive care unit (O2‐ICU). clinicaltrials.gov/ct2/show/NCT02321072 (first received 9 December 2014).
NCT02713451 {published data only}
NCT02713451. Liberal oxygenation versus conservative oxygenation in ARDS (LOCO2). clinicaltrials.gov/ct2/show/NCT02713451 (first received 18 March 2016).
NCT03141099 {published data only}
NCT03141099. Blood pressure and OXygenation targets after OHCA (BOX). clinicaltrials.gov/ct2/show/NCT03141099 (first received 4 May 2017).
NCT03174002 {published data only}
NCT03174002. Handling oxygenation targets in the intensive care unit (HOT‐ICU). clinicaltrials.gov/ct2/show/NCT03174002 (first received 2 June 2017).
NCT03287466 {published data only}
Targeted OXYgen therapy in critical illness (TOXYC). clinicaltrials.gov/ct2/show/NCT03287466 (first received 19 September 2017).
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