Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA
Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
BMJ Open. 2022 Nov 25;12(11):e066007. doi: 10.1136/bmjopen-2022-066007.
Heated, humidified, high-flow nasal cannula oxygen therapy has been used as a therapy for hypoxic respiratory failure in numerous clinical settings. To date, limited data exist to guide appropriate use following cardiac surgery, particularly among patients at risk for experiencing reintubation. We hypothesised that postextubation treatment with high-flow nasal cannula would decrease the all-cause reintubation rate within the 48 hours following initial extubation, compared with usual care.
Adult patients undergoing cardiac surgery (open surgery on the heart or thoracic aorta) will be automatically enrolled, randomised and allocated to one of two treatment arms in a pragmatic randomised controlled trial at the time of initial extubation. The two treatment arms are administration of heated, humidified, high-flow nasal cannula oxygen postextubation and usual care (treatment at the discretion of the treating provider). The primary outcome will be all-cause reintubation within 48 hours of initial extubation. Secondary outcomes include all-cause 30-day mortality, hospital length of stay, intensive care unit length of stay and ventilator-free days. Interaction analyses will be conducted to assess the differential impact of the intervention within strata of predicted risk of reintubation, calculated according to our previously published and validated prognostic model.
Vanderbilt University Medical Center IRB approval, 15 March 2021 with waiver of written informed consent. Plan for publication of study protocol prior to study completion, as well as publication of results.
clinicaltrials.gov, NCT04782817 submitted 25 February 2021.
29 August 2022. Version 2.0.
在许多临床环境中，加热、湿化、高流量鼻导管氧疗已被用作治疗低氧性呼吸衰竭的方法。迄今为止，关于心脏手术后的适当使用方法，仅有有限的数据可提供指导，尤其是对于有再次插管风险的患者。我们假设，与常规护理相比，心脏手术后患者在初始拔管后使用高流量鼻导管进行拔管后治疗，会降低 48 小时内的全因再插管率。
将在初始拔管时，自动纳入、随机分配并分配到一项实用随机对照试验中的两个治疗组的成年心脏手术（心脏或胸主动脉的开放性手术）患者。两个治疗组分别为：拔管后给予加热、湿化、高流量鼻导管吸氧和常规护理（由治疗提供者决定治疗方法）。主要结局是初始拔管后 48 小时内的全因再插管。次要结局包括全因 30 天死亡率、住院时间、重症监护病房时间和无呼吸机天数。将进行交互分析，以根据我们之前发表和验证的预测再插管风险的预后模型，评估干预措施在再插管风险分层中的差异影响。
范德堡大学医学中心 IRB 于 2021 年 3 月 15 日批准，豁免书面知情同意书。计划在研究完成前发表研究方案，并公布研究结果。
clinicaltrials.gov，NCT04782817，于 2021 年 2 月 25 日提交。
2022 年 8 月 29 日。版本 2.0。
