Objective To determine leakage for two neonatal continuous positive airway pressure (CPAP) interfaces and evaluate leak-corrective manoeuvres. Design The ToNIL (Trial of NCPAP Interface Leakage) study was a randomised, clinical, cross-over trial with data collection between August 2018 and October 2019. The primary outcome was blinded to the treating staff. Setting One secondary, 8-bed neonatal intensive care unit (NICU) and three larger (>15 beds), academic NICU referral centres. Patients Newborn infants with CPAP were screened (n=73), and those with stable spontaneous breathing, low oxygen requirement, postmenstrual age (PMA) over 28 weeks and no comorbidities were eligible. In total, 50 infants were included (median PMA 33 completed weeks). Interventions Leakage was measured for both prongs and nasal mask, before and after leak-corrective manoeuvres. Interface application was performed in a randomised order by a nurse, blinded to the measured leakage. Main outcome measures 30 s average leakage, measured in litres per minute (LPM). Results Analyses showed a significantly lower leakage (mean difference 0.86 LPM, 95% CI 0.07 to 1.65) with prongs (median 2.01 LPM, IQR 1.00–2.80) than nasal mask (median 2.45 LPM, IQR 0.99–5.11). Leak-corrective manoeuvres reduced leakage significantly for both prongs (median 1.22 LPM, IQR 0.54–1.87) and nasal mask (median 2.35 LPM, IQR 0.76–4.75). Conclusions Large leakages were common for both interfaces, less with prongs. Simple care manoeuvres reduced leakage for both interfaces. This is the first report of absolute leakage for nasal interfaces and should encourage further studies on leakage during CPAP treatment. Data are available on reasonable request. Deidentified participant data and full trial protocol available from corresponding author to researchers who provide a methodologically sound proposal. Reuse of data permitted to achieve aims in the approved proposal.

中文翻译：

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新生儿 CPAP 治疗期间的界面泄漏：一项随机、交叉试验

目的确定两个新生儿持续气道正压通气 (CPAP) 接口的泄漏并评估泄漏纠正操作。设计 ToNIL（NCPAP 界面泄漏试验）研究是一项随机、临床、交叉试验，数据收集时间为 2018 年 8 月至 2019 年 10 月。主要结果对治疗人员不知情。设置 一个二级、8 个床位的新生儿重症监护病房 (NICU) 和三个更大的（>15 个床位）学术 NICU 转诊中心。患者 患有 CPAP 的新生儿接受了筛查 (n=73)，并且那些自主呼吸稳定、需氧量低、经后年龄 (PMA) 超过 28 周且没有合并症的婴儿符合条件。总共包括 50 名婴儿（中位 PMA 为 33 周）。测量了鼻塞和鼻罩的干预措施泄漏，在泄漏纠正操作之前和之后。接口应用由护士以随机顺序执行，对测量的泄漏不知情。主要结果测量 30 秒平均泄漏，以每分钟升 (LPM) 为单位。结果 分析显示，与鼻罩（中值 2.45 LPM，IQR 0.99-5.11）相比，鼻罩（中值 2.01 LPM，IQR 1.00-2.80）的泄漏（平均差异 0.86 LPM，95% CI 0.07 至 1.65）显着降低。泄漏纠正操作显着减少了鼻塞（中值 1.22 LPM，IQR 0.54-1.87）和鼻罩（中值 2.35 LPM，IQR 0.76-4.75）的泄漏。结论 两种接口都有大量泄漏，插脚较少。简单的护理操作减少了两个接口的泄漏。这是鼻界面绝对渗漏的第一份报告，应鼓励进一步研究 CPAP 治疗期间的渗漏。可应合理要求提供数据。来自通讯作者的未识别参与者数据和完整的试验方案可提供给提供方法学上合理建议的研究人员。允许重复使用数据以实现已批准提案中的目标。