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临床试验/NCT04860648
NCT04860648Unknown不适用

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 592 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
592
试验地点
1
主要终点
the incidence of postoperative pulmonary complications

研究概览

简要总结

Postoperative pulmonary complications (PPCs) occur in many patients, especially those with high risks, and are associated with increased hospital length of stay, morbidity and costs of care. According to European Perioperative Clinical Outcome definitions, major pulmonary complications include atelectasis, respiratory infection, pleural effusion, and pneumothorax. Because identifying patients at high risk for PPCs may allow earlier treatment, predictive scores ( the Assess Respiratory Risk in Surgical Patients in Catalonia score [ARISCAT]) have been developed.Lung ultrasound (LUS) is more accurate than chest X-ray in diagnosing pulmonary complications, and lung ultrasound performed in the postanesthesia care unit may identify patients at higher risk for pulmonary complications. So we aimed to study if lung ultrasound can guide the prevention of PPCs in moderate to high risk patients.

详细描述

patients recruited are randomized into the two groups: LUS group and Control group. Patients in LUS group received ultrasound examination and guided the treatment according to the ultrasound results, while the control group did not receive ultrasound examination, just the same as the routine clinical practice. This study aims to explore whether ultrasound-guided clinical treatment can reduce the incidence of postoperative pulmonary complications in moderate to highrisk patients. Before operation, informed consent was signed according to the inclusion criteria, and the incidence of pulmonary complications within 5 days after operation (or before discharge) was recorded after operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age≥18 Estimated ARISCAT score ≥26 分

排除标准

  • transferred to ward or ICU directly day surgery (patients won't stay in hospital longer than 24 hours after surgery actual ARISCAT score < 26 分 the technical incompatibility of the acoustic window patients refused pregnant

结局指标

主要结局

the incidence of postoperative pulmonary complications

时间窗: within 5 days after operation or before discharge, whichever came first

postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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