Abstract：Objective To explore the characteristics of acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) programs registered in Chinese clinical trial registries. Methods Clinical trials of ALI/ARDS registered from the inception of the center to June 30, 2021 were retrieved and the information was counted. Results Ninety-six projects were screened, with the majority of major research units in Shandong and Shanghai (12.50% each), and 79.17% were single-center trials. The 92 projects with defined sample sizes were expected to recruit a total of 23 310 patients, with a sample size range of 9 to 5 000 patients. The types of studies were mostly observational studies (47.92%), interventional randomized controlled trials (42.71%), and registration information such as blinded use and randomization concealment still needs to be improved. 44 (45.83%) studies involved comorbidities. The interventions involved combined Chinese and western medicine treatment, western medicine treatment and non-pharmaceutical treatment, etc. The specimens collected were mainly blood and bronchoalveolar lavage fluid, and the observation indexes included clinically relevant indexes, physical and chemical examinations, and scoring scales. Conclusion There is a lack of registration information in some projects, and the quality of registration needs to be further improved; multi-center and large sample size clinical studies are still needed for a variety of comorbidities and diverse interventions in ALI/ARDS; outcome indicators are abundant and scattered, and attention can be paid to the development and application of core indicator sets to promote the generation of high-quality evidence-based evidence to help improve clinical diagnosis and treatment, and provide reference for future research directions in this field.
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