Background and Aims Current guidelines recommend 6 h of solid food and 2 h of clear liquid fasting for patients undergoing cardiac procedures with conscious sedation. There are no data to support this practice, and previous single-centre studies support the safety of removing fasting requirements. The objective of this study was to determine the non-inferiority of a no-fasting strategy to fasting prior to cardiac catheterization procedures which require conscious sedation. Methods This is a multicentre, investigator-initiated, non-inferiority, randomized trial conducted in Australia with a prospective open-label, blinded endpoint design. Patients referred for coronary angiography, percutaneous coronary intervention, or cardiac implantable electronic device (CIED)-related procedures were enrolled. Patients were randomized 1:1 to fasting as normal (6 h solid food and 2 h clear liquid) or no-fasting requirements (encouraged to have regular meals but not mandated to do so). Recruitment occurred from 2022 to 2023. The primary outcome was a composite of aspiration pneumonia, hypotension, hyperglycaemia, and hypoglycaemia assessed with a Bayesian approach. Secondary outcomes included patient satisfaction score, new ventilation requirement (non-invasive and invasive), new intensive care unit admission, 30-day readmission, 30-day mortality, 30-day pneumonia. Results A total of 716 patients were randomized with 358 in each group. Those in the fasting arm had significantly longer solid food fasting (13.2 vs. 3.0 h, Bayes factor >100, indicating extreme evidence of difference) and clear liquid fasting times (7.0 vs. 2.4 h, Bayes factor >100). The primary composite outcome occurred in 19.1% of patients in the fasting arm and 12.0% of patients in the no-fasting arm. The estimate of the mean posterior difference in proportions with credibility interval (CI) in the primary composite outcome was −5.2% (95% CI −9.6 to −.9), favouring no fasting. This result confirms the non-inferiority (posterior probability >99.5%) and superiority (posterior probability 99.1%) of no fasting for the primary composite outcome. The no-fasting arm had improved patient satisfaction scores with a posterior mean difference of 4.02 points (95% CI 3.36–4.67, Bayes factor >100). Secondary outcome events were observed to be similar. Conclusions In patients undergoing cardiac catheterization and CIED-related procedures, no fasting was non-inferior and superior to fasting for the primary composite outcome of aspiration pneumonia, hypotension, hyperglycaemia, and hypoglycaemia. Patient satisfaction scores were significantly better with no fasting. This supports removing fasting requirements for patients undergoing cardiac catheterization laboratory procedures that require conscious sedation.

中文翻译：

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导管插入术实验室操作前禁食与不禁食：SCOFF 试验


背景和目标 目前的指南建议接受清醒镇静心脏手术的患者禁食 6 小时固体食物和 2 小时透明液体。没有数据支持这种做法，以前的单中心研究支持取消禁食要求的安全性。本研究的目的是确定在需要清醒镇静的心导管插入术之前不禁食策略不劣于禁食。方法 这是一项在澳大利亚进行的多中心、研究者发起、非劣效性、随机试验，采用前瞻性开放标签、盲法终点设计。纳入转诊接受冠状动脉造影、经皮冠状动脉介入治疗或心脏植入式电子设备 （CIED） 相关手术的患者。患者以 1：1 的比例随机分配至正常禁食组（6 小时固体食物和 2 小时清流）或不禁食要求组（鼓励规律进餐，但未强制要求）。招聘于 2022 年至 2023 年进行。主要结局是吸入性肺炎、低血压、高血糖和用贝叶斯方法评估的低血糖的复合结局。次要结局包括患者满意度评分、新通气需求 （无创和有创）、新的重症监护病房收治、30 天再入院、30 天死亡率、30 天肺炎。结果 共 716 例患者随机分组，每组 358 例。空腹组的固体食物禁食时间明显更长 （13.2 vs. 3.0 h，贝叶斯因子 >100，表明存在差异的极端证据）和透明液体禁食时间 （7.0 vs. 2.4 h，贝叶斯因子 >100）。主要复合结局发生在空腹组 19.1% 的患者和不禁食组 12.0% 的患者。 在主要复合结局中，可信区间 （CI） 比例的平均后验差异估计值为 -5.2% （95% CI -9.6 至 -.9），支持不禁食。这一结果证实了主要复合结局不禁食的非劣效性 （后验概率 >99.5%） 和优效性 （后验概率 99.1%）。不禁食组提高了患者满意度评分，后验平均差为 4.02 分 （95% CI 3.36-4.67，贝叶斯因子 >100）。观察到次要结局事件相似。结论 在接受心导管插入术和 CIED 相关手术的患者中，对于吸入性肺炎、低血压、高血糖和低血糖的主要复合结局，无空腹不劣于和优于空腹。无禁食的患者满意度评分明显更高。这支持取消接受需要清醒镇静的心导管实验室手术的患者的禁食要求。