Fubini Pietro Elias, Savoldelli Georges Louis, Beckmann Tal Sara, Samer Caroline Flora, Suppan Mélanie
Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
Clinical Pharmacology and Toxicology Division, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
JMIR Res Protoc. 2024 Jan 3;13:e53679. doi: 10.2196/53679.
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.
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.
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.
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.
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.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53679.
局部麻醉药常用于缓解医疗或外科手术过程中的疼痛。其使用通常被认为是安全的，但超过最大推荐剂量可能会导致局部麻醉药全身毒性，这是一种罕见但可能致命的并发症。因此，在进行局部麻醉之前确定最大安全剂量是必不可少的，但相关规则往往不明确，且影响剂量计算的因素众多。移动健康应用程序已被证明有助于临床决策，但目前大多数可用的应用程序存在显著局限性。局部麻醉药剂量计算器（LoAD Calc）应用程序旨在通过考虑所有相关参数来克服这些局限性。在将此应用程序部署到临床环境之前，应进行测试以确定其有效性以及临床医生是否愿意使用它。
主要目的是通过书面模拟病例评估LoAD Calc应用程序的有效性。次要目的是确定医生是否认为此应用程序比他们通常使用的方法更简便、更快捷且更安全。
我们描述了一项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医生参与。参与者将被要求使用3种不同的局部麻醉药计算10个模拟临床病例中的局部麻醉药最大剂量。将使用与开发LoAD Calc相同的计算规则手动确定最大安全剂量，而不使用该应用程序本身。任何高于正确剂量（向上取整）的剂量都将被视为过量，而低于剂量将被定义为最佳计算剂量减去20%（向下取整）。随机分组将根据当前职位（住院医生与注册医生）进行分层。分配到LoAD Calc（实验组）的参与者将使用LoAD Calc应用程序计算局部麻醉药的最大安全剂量。分配到对照组的参与者将被要求使用他们通常使用的方法。主要结局将是总体过量率。次要结局将包括根据理想体重和实际体重以及每种特定局部麻醉药的过量率、总体低于剂量率以及完成这些计算所需的时间。还将评估该应用程序的可用性。
需要46名参与者的样本量才能以90%的检验效能检测出10%的差异。因此，设定了50名参与者的目标，以考虑损耗和排除标准。我们预计招募工作将于2023年冬季开始，2024年春季进行数据分析，并在2024年底得出结果。
本研究应确定旨在计算局部麻醉药最大安全剂量的移动健康应用程序LoAD Calc是否比传统的局部麻醉药计算方法更安全、更高效。
国际注册报告识别码（IRRID）：PRR1-10.2196/53679。
