背景:局部麻醉药(LA)经常用于减轻药物或外科手术期间的疼痛。它们的使用通常被认为是安全的,但超过最大推荐剂量会导致LA全身毒性,一种罕见但可能致命的并发症.因此,在进行局部麻醉之前,必须确定最大安全剂量,但规则往往不明确,影响剂量计算的因素很多。移动健康应用程序已被证明有助于临床决策,但大多数当前可用的应用程序都存在明显的局限性。局部麻醉剂剂量计算器(LoADCalc)应用程序旨在通过考虑所有相关参数来克服这些限制。在临床环境中部署此应用程序之前,应该对其进行测试,以确定其有效性以及临床医生是否愿意使用它。
目的:主要目的将是通过书面模拟案例评估LoADCalc应用程序的有效性。次要目标将是确定医生是否发现这个应用程序更容易,更快,并且比他们通常使用的方法更安全。
方法:我们描述了一个平行组随机对照试验方案。将邀请在日内瓦大学医院工作的麻醉师参加。参与者将被要求使用3种不同的LA计算10个模拟临床病例中LA的最大剂量。最大安全剂量将使用用于开发LoADCalc的相同计算规则手动确定。不使用应用程序本身。过量将被视为高于正确剂量的任何剂量,四舍五入为上级整数,而剂量不足将被定义为最佳计算剂量减去20%,四舍五入为下整数。随机化将根据当前位置(居民与登记员)进行分层。分配给LoADCalc(实验)组的参与者将使用LoADCalc应用程序来计算最大安全LA剂量。那些分配给对照组的人将被要求使用他们通常使用的方法。主要结果将是总体用药过量率。次要结果将包括根据理想和实际体重以及每个特定LA的过量发生率。总体剂量不足率,以及完成这些计算所需的时间。该应用程序的可用性也将被评估。
结果:将需要46名参与者的样本量,以90%的功率检测10%的差异。因此,设定了50名参与者的目标,以考虑减员和排除标准.我们预计招聘将在2023年冬季开始,数据分析将在2024年春季开始,结果将在2024年底。
结论:本研究应确定LoADCalc,一个移动健康应用程序,旨在计算最大安全剂量,比传统的LA计算方法更安全、更高效。
■PRR1-10.2196/53679。
BACKGROUND: Local anesthetics (LAs) are regularly used to alleviate pain during medical or surgical procedures. Their use is generally considered safe, but exceeding the maximum recommended doses can lead to LA systemic toxicity, a rare but potentially lethal complication. Determining maximum safe doses is therefore mandatory before performing local anesthesia, but rules are often unclear and the factors affecting dose calculation are numerous. Mobile health apps have been shown to help clinical decision-making, but most currently available apps present significant limitations. The Local Anesthetics Dose Calculator (LoAD Calc) app was designed to overcome these limitations by taking all relevant parameters into account. Before deploying this app in a clinical setting, it should be tested to determine its effectiveness and whether clinicians would be willing to use it.
OBJECTIVE: The primary objective will be to evaluate the effectiveness of the LoAD Calc app through written simulated cases. The secondary objective will be to determine whether physicians find this app easier, faster, and safer than the methods they generally use.
METHODS: We describe a parallel-group randomized controlled trial protocol. Anesthesiologists working at the Geneva University Hospitals will be invited to participate. Participants will be asked to compute the maximum dose of LA in 10 simulated clinical cases using 3 different LAs. The maximum safe dose will be determined manually using the same calculation rules that were used to develop LoAD Calc, without using the app itself. An overdose will be considered any dose higher than the correct dose, rounded to the superior integer, while an underdose will be defined as the optimal calculated dose minus 20%, rounded to the inferior integer. Randomization will be stratified according to current position (resident vs registrar). The participants allocated to the LoAD Calc (experimental) group will use the LoAD Calc app to compute the maximum safe LA doses. Those allocated to the control group will be asked to use the method they generally use. The primary outcome will be the overall overdose rate. Secondary outcomes will include the overdose rate according to ideal and actual body weight and to each specific LA, the overall underdose rate, and the time taken to complete these calculations. The app\'s usability will also be assessed.
RESULTS: A sample size of 46 participants will be needed to detect a difference of 10% with a power of 90%. Thus, a target of 50 participants was set to allow for attrition and exclusion criteria. We expect recruitment to begin during the winter of 2023, data analysis in the spring of 2024, and results by the end of 2024.
CONCLUSIONS: This study should determine whether LoAD Calc, a mobile health app designed to compute maximum safe LA doses, is safer and more efficient than traditional LA calculation methods.
UNASSIGNED: PRR1-10.2196/53679.