Effect of EIT-guided PEEP titration on prognosis of patients with moderate to severe ARDS: study protocol for a multicenter randomized controlled trial

Abstract

Background Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Electrical impedance tomography (EIT)-guided positive end-expiratory pressure (PEEP) titration can achieve the compromise between lung overdistension and collapse which may minimize ventilator-induced lung injury in these patients. However, the effect of EIT-guided PEEP titration on the clinical outcomes remains unknown. The objective of this trial is to investigate the effects of EIT-guided PEEP titration on the clinical outcomes for moderate or severe ARDS, compared to the low fraction of inspired oxygen (FiO2)-PEEP table. Methods This is a prospective, multicenter, single-blind, parallel-group, adaptive designed, randomized controlled trial (RCT) with intention-to-treat analysis. Adult patients with moderate to severe ARDS less than 72 h after diagnosis will be included in this study. Participants in the intervention group will receive PEEP titrated by EIT with a stepwise decrease PEEP trial, whereas participants in the control group will select PEEP based on the low FiO2-PEEP table. Other ventilator parameters will be set according to the ARDSNet strategy. Participants will be followed up until 28 days after enrollment. Three hundred seventy-six participants will be recruited based on a 15% decrease of 28-day mortality in the intervention group, with an interim analysis for sample size re-estimation and futility assessment being undertaken once 188 participants have been recruited. The primary outcome is 28-day mortality. The secondary outcomes include ventilator-free days and shock-free days at day 28, length of ICU and hospital stay, the rate of successful weaning, proportion requiring rescue therapies, compilations, respiratory variables, and Sequential Organ Failure Assessment (SOFA). Discussion As a heterogeneous syndrome, ARDS has different responses to treatment and further results in different clinical outcomes. PEEP selection will depend on the properties of patients and can be individually achieved by EIT. This study will be the largest randomized trial to investigate thoroughly the effect of individual PEEP titrated by EIT in moderate to severe ARDS patients to date. Trial registration ClinicalTrial.gov NCT05207202. First published on January 26, 2022.

Ultrassonografia pulmonar na titulação de PEEP em pacientes com SDRA: Uma revisão narrativa

“…Uma aeração pulmonar normal é caracterizada pela presença de linhas A horizontais que se estendem além da linha pleural. Em contrapartida, a presença de múltiplas linhas B verticais, comumente conhecidas como "caudas de cometa," espaçadas de maneira definida, indica uma diminuição moderada na aeração pulmonar (Cho et al, 2020;Yuan et al, 2023). Esse fenômeno pode ser resultado de condições como síndrome intersticial, quando as linhas B estão regularmente espaçadas a 7 mm de distância, indicando o espessamento dos septos interlobulares, ou de focos disseminados de pneumonia, quando as linhas B apresentam espaçamento (Bosso et al, 2023;Cortes-Puentes et al, 2023;Salem et al, 2020).…”

“…Reconhece-se que a definição adequada do PEEP é um aspecto importante de uma estratégia de ventilação que visa proteger os pulmões, não apenas uma estratégia para melhorar a oxigenação (Boesing et al, 2022;Yuan et al, 2023) Estabelecer níveis de PEEP de 5 cm H2O pode ser prejudicial na fase aguda da SDRA e aumentar exacerbamente ela a níveis maiores que 15 cmH2O inclui os efeitos adversos hemodinâmicos, renais e neurológicos (Somhorst et al, 2022).…”

“…Vale ressaltar que não existe um método universalmente aceito como padrão-ouro para a determinação precisa do nível ideal de PEEP (Boesing et al, 2022;Yuan et al, 2023). Nessa perspectiva métodos foram propostos para titulação da PEEP em um paciente individual com SDRA, incluindo troca gasosa, complacência, curva pressão-volume, índice de estresse, manometria esofágica, volume pulmonar, exames de imagem, tomografia de bioimpedância elétrica e ultrassongrafia (Boesing et al, 2022;Heunks et al, 2023;Kim et al, 2020;Somhorst et al, 2022).…”

Recent advances in cardiorespiratory monitoring in acute respiratory distress syndrome patients

“…Robust data on clinical outcomes of PEEP titration techniques are still lacking in the literature. A multicenter randomized controlled trial is actually going on to find out differences on clinical outcomes in ARDS patients whose PEEP is titrated using either EIT-based techniques or PEEP/FiO 2 tables [ 63 ].…”