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Doctoral Thesis
DOI
https://doi.org/10.11606/T.5.2021.tde-19082021-150050
Document
Author
Full name
Marcelo Luz Pereira Romano
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2020
Supervisor
Committee
Cavalcanti, Alexandre Biasi (President)
Pincelli, Mariângela Pimentel
Malbouisson, Luiz Marcelo Sá
Victorino, Josué Almeida
Title in Portuguese
Estudo clínico randomizado piloto avaliando ventilação mecânica com driving pressure limitada em comparação à estratégia convencional (ARDSNet) em pacientes com SARA
Keywords in Portuguese
Driving pressure
Estado terminal.
Lesão pulmonar induzida por ventilador
Respiração artificial
Síndrome da angústia respiratória aguda
Volume de ventilação pulmonar
Abstract in Portuguese
Introdução: Evidências de estudos observacionais em síndrome da angústria respiratória aguda (SARA) demonstram que a driving pressure é fortemente associada à lesão pulmonar e à mortalidade, de modo independente dos valores de PEEP, volume corrente (Vt) ou pressão de platô. Objetivo: Avaliar a factibilidade de testar estratégia de ventilação mecânica com driving pressure limitada em comparação à estratégia convencional (estratégia ARDSNet) em pacientes com SARA e que apresentavam driving pressure maior ou igual a 13 cmH2O, com Vt de 6 mL/kg de peso predito (PBW). Desenho, métodos e participantes: Ensaio clínico randomizado piloto, multicêntrico, conduzido em 5 UTI´s brasileiras entre junho de 2015 e fevereiro de 2017, com alocação sigilosa e com análise por intenção de tratar, comparando uma estratégia de ventilação mecânica com driving pressure limitada, versus a estratégia convencional (estratégia ARDSNet) em pacientes com SARA. Intervenções: Os pacientes que foram alocados para a estratégia driving pressure, foram ventilados na modalidade volume-controlado ou pressão de suporte, com volume titulado entre 4 e 8 mL/kg PBW, para manter driving pressure de 10 cmH2O (ou a menor possível). O grupo controle foi ventilado conforme o protocolo ARDSNet, com volume corrente de 6 mL/kg PBW, podendo ser reduzido (para até 4 mL/kg PBW) se platô >30 cmH2O. Desfecho primário: O desfecho primário foi a driving pressure nos dias 1 a 3. Resultados: Foram randomizados 31 pacientes, 16 para o grupo driving pressure limitada e 15 para o grupo estratégia convencional. As variáveis ventilatórias e gasométricas estavam balanceadas entre os grupos no início do estudo (baseline). A maioria dos pacientes apresentava SARA leve, com relação PaO?/ FIO? média de 215 (desvio padrão [DP], 95). A driving pressure média de base foi de 15 cmH2O ([DP], 2,6) nos grupos. Em comparação ao grupo convencional, a driving pressure reduziu em média 4,6 cmH2O (IC 95% 2,8 a 6,5; P<0,001) no grupo driving pressure limitada, a partir da primeira hora até o terceiro dia. Não houve diferença estatisticamente significativa nos seguintes desfechos secundários: mortalidade nos primeiros 28 dias de interação hospitalar; ocorrência de barotrauma nos primeiros sete dias de internação; presença de acidose metabólica severa (ph <7,1) desde a primeira hora até o sétimo dia de internação e a necessidade de reintubação em 28 dias. Conclusão e relevância: Em pacientes com SARA, uma estratégia de ventilação mecânica com driving pressure limitada por meio do uso de volumes correntes muito baixos é factível em comparação à estratégia convencional.
Title in English
Pilot randomized clinical study evaluating mechanical ventilation with limited driving pressure compared to conventional strategy (ARDSNet) in patients with ARDS
Keywords in English
Acute respiratory distress syndrome
Artificial respiration, Tidal volume
Critical illness
Driving pressure
Ventilator-induced lung injury
Abstract in English
Importance: Evidence from observational studies in acute respiratory distress syndrome (ARDS) indicate that driving pressure may be associated with pulmonary injury and mortality, regardless the levels of positive end expiratory pressure (PEEP), tidal volume (Vt) or plateau pressure. Objective: To evaluate the feasibility of testing a driving pressure-limited strategy in comparison with a conventional lung protective ventilation strategy (ARDSNet strategy), in patients with ARDS and driving pressure of 13 cmH2O or higher with Vt of 6mL/kg of predicted body weight (PBW). Design, setting and participants: Multicenter pilot randomized clinical trial conducted in 5 Brazilian ICUs between June 2015 and February 2017, with concealed allocation and intention-to-treat analysis, comparing a mechanical ventilation strategy with limited driving pressure versus conventional strategy (ARDSNet strategy) in patients with ARDS. Interventions: Patients allocated to the driving pressure-limited strategy were ventilated with volume-controlled or pressure support ventilation modes, tidal volume titrated to 4-8 mL/Kg PBW, aiming a driving pressure of 10 cmH2O (or the lowest possible). Control group was ventilated according to the ARDSNet protocol, using a tidal volume of 6 mL/kg PBW, allowing to be set down to 4 mL/Kg PBW if plateau pressure was higher than 30 cmH2O. Main outcomes and measures: Primary endpoint was driving pressure on days 1 to 3. Results: Thirty-one patients were randomized, 16 to the driving pressure-limited group and 15 to the conventional strategy group. Most patients had mild ARDS with mean PaO2/FiO2 ratio of 215 (standard deviation [SD], 95). Baseline driving pressure was 15,0 cmH2O (SD 2.6) in both groups. In comparison to the conventional strategy, driving pressure from the first hour to the 7th day was 4.6 cmH2O lower in the driving pressure-limited group (95% confidence interval [CI], 2.8 - 6.5; p<0.001). We did not find significant differences in the secondary endpoints: mortality in the first 28 days of hospital admission, barotrauma within 7 days, severe metabolic acidosis - Ph <7.10 - from the first hour to the seventh day after admission or reintubation in 28 days. Conclusions and relevance: In ARDS patients, a trial assessing the effects of a driving pressurelimited strategy using very low tidal volumes versus a conventional ventilation strategy on clinical outcomes is feasible.
 
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Publishing Date
2021-08-19
 
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