抽象
介绍Hypoxaemia and hyperoxaemia may occur after surgery, with related complications. This multicentre randomised trial evaluated the impact of automated closed-loop oxygen administration after high-risk abdominal or thoracic surgeries in terms of optimising the oxygen saturation measured by pulse oximetry time within target range.
方法在拔管后,术后肺部并发症的中间体患者随机被随机化为“标准”或“自动化”闭环氧给药。主要结果是氧合范围内的时间百分比,在3天框架中。二次结果是氧气下缺氧和高血症的时间。
结果Among the 200 patients, time within range was higher in the automated group, both initially (≤3 h; 91.4±13.7%与40.2±35.1% of time, difference +51.0% (95% CI −42.8–59.2%); p<0.0001) and during the 3-day period (94.0±11.3%与62.1±23.3%,+ 31.9% (95% CI 26.3的差异–37.4%); p<0.0001). Periods of hypoxaemia were reduced in the automated group (≤3 days; 32.6±57.8 min (1.2±1.9%)与370.5±594.3 min (5.0±11.2%), difference −10.2% (95% CI −13.9–−6.6%); p<0.0001), as well as hyperoxaemia under oxygen (≤3 days; 5.1±10.9 min (4.8±11.2%)与177.9±277.2分钟(27.0±23.8%),差异-22.0%(95%CI -27.6--16.4%);P <0.0001)。Kaplan-Meier分析描绘了低氧血症(p = 0.01)和严重低氧血症(p = 0.0003)的显着差异,基团之间有利于自动化组的发生。与自动化组相比,25名患者在标准组3天内经历了> 10%的整个监测时间的10%(P <0.0001)。
结论Automated closed-loop oxygen administration promotes greater time within the oxygenation target, as compared to standard manual administration, thus reducing the occurrence of hypoxaemia and hyperoxaemia.
抽象
Following high-risk surgery, automated closed-loop oxygen administration promotes a higher time within range as compared to standard manual administrationhttps://bit.ly/2ZPHT5Y
脚注
本文提供了补充材料www.qdcxjkg.com.
这项研究是注册Clinicaltrials.gov.with identifiernct02546830..
数据可用性:学习协议,SAP,知情同意书和学习报告将可供任何希望访问对促进者的个人需求的人员。
Author contributors: E. L'Her and F. Lellouche designed this study, drafted the manuscript of the protocol and critically revised the manuscript. E. L'Her, S. Jaber, D. Verzilli, C. Jacob, B. Huiban, E. Futier, T. Kerforne, V. Pateau, P-A. Bouchard, M. Consigny and F. Lellouche participated in the conduct of the study. M. Consigny and E. Nowak participated in the protocol methodological assessment and statistical plan. All authors read and approved the final manuscript.
Ethics approval: The institutional review board of the University Hospital of Brest (France) approved the trial for all French centres (IDRCB RB14-060). The institutional review board from the Québec Heart and Lung Institute (Canada) approved the trial for their own centre. Any protocol modification will be submitted for review and approval by the ethics committee. The FreeO2Post-Op study is conducted in accordance with the declaration of Helsinki and was registered on September 11, 2015 athttp://www.clinicaltrials.gov.使用试用识别号码nct02546830.. First patient inclusion was performed on January 14, 2016.
兴趣冲突:E. L'她在研究期间从oxynov报告;史密斯医疗,个人费用和其他来自塞巴娜医疗的GE Healthcare,赠款和个人费用的个人费用,在提交的工作之外。此外,E. L'HER具有用于将许可的氧气提供氧气的专利方法和装置。
利益冲突:S. Jaber在研究期间向Drager,Fisher-Paykel,Baxter,Fresenius-Xenios和Medtronic报告个人费用。
Conflict of interest: D. Verzilli has nothing to disclose.
利益冲突:C.雅各没有披露。
利益冲突:B.惠班无所事事。
利益冲突:E. yever报告Draber Medical,GE Healthcare,Orion Pharma和Edfwards Lifesciences的咨询费,Fresenius Kabi和Getinge的讲座,以及Fisher和Paykel Healthcare的非财政支持,在该研究期间。
Conflict of interest: T. Kerforne has nothing to disclose.
利益冲突:V. Poleau在研究中的oxynov报告了其他oxynov。
Conflict of interest: P-A. Bouchard has nothing to disclose.
兴趣冲突:M.寄托无需披露。
利益冲突:在研究期间,奥克约州的leellouche报告了其他oxynov。
支持声明:本试验由法国卫生部资助于2014年,从区域医院临床研究计划(Program Horeverier De Recherche CliniqueIrnerégionalHugo 2012-199)获得。赞助商在研究设计和行为中没有作用;数据的收集,管理,分析和解释;或制定和批准手稿。本文的资金信息已存入Crossref Funder Registry.
- 收到January 30, 2020.
- Accepted2020年7月17日。
- 复制right ©ERS 2021