Complications in acute respiratory distress syndrome: a systematic review and meta-analysis

Background: Acute respiratory distress syndrome (ARDS) carries substantial morbidity and mortality. Supportive care with invasive mechanical ventilation (IMV) remains a cornerstone of management. The breadth and prevalence of complications experienced by patients with ARDS undergoing IMV is unclear. Methods: We performed a systematic review and meta-analysis to quantify complications reported by studies featuring patients with ARDS undergoing IMV. We searched MEDLINE, MEDLINE In-Process/ePubs, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and ClinicalTrials.gov from database inception until November 28, 2025. We included randomized controlled trials (RCTs) and cohort studies featuring adults with ARDS undergoing IMV that reported at least one complication. We excluded studies of COVID-19, studies with 25% or more patients on extracorporeal life support, and studies with under 200 participants. We extracted data on any reported clinical complication, based on author definitions. For complications reported by three or more studies we performed a random effects meta-analysis of logit-transformed complication proportions using inverse-variance weighting. Results: Of 25,421 citations, we reviewed 2620 full texts and included 53 studies (25 RCTs and 28 cohort studies). Complications were variably and infrequently reported. Only barotrauma, ventilator associated pneumonia (VAP), hypotension, arrhythmia, stroke, myopathy and cardiac arrest were reported by three or more RCTs. In cohort studies, barotrauma, VAP, acute renal failure, sepsis and bacteremia were reported by three or more studies. All estimates featured considerable heterogeneity. Conclusions: In this systematic review of studies including patients with ARDS receiving IMV, reporting of complications was variable and infrequent. Our synthesis was descriptive and did not investigate causality. Future studies should establish consensus on the spectrum of complications to improve reporting and help evaluate the risks and benefits of novel therapies. We propose a process to develop a core outcome set for complications experienced by patients with ARDS undergoing IMV. Preliminary results of this work were presented at the ESICM LIVES conference in October 2021 Supplementary Information: The online version contains supplementary material available at 10.1186/s13054-026-05978-y.