Department of Neurology, Yale School of Medicine, New Haven, CT, United States.
Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, United States.
Resuscitation. 2024 Oct;203:110397. doi: 10.1016/j.resuscitation.2024.110397. Epub 2024 Sep 13.
Temperature control is a complex bundled intervention; the synergistic impact of each individual component is ill defined and underreported. Resultantly, the influence of parameter optimization on temperature control's overall neuroprotective effect remains poorly understood. To characterize variability in temperature control parameters and barriers to short pre-induction and induction times, we surveyed sites enrolling in an ongoing multicenter clinical trial.
This was a cross-sectional, survey study evaluating temperature control practices within the Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP) trial (NCT04217551). A 23-question web-based survey (Qualtrics) was distributed to the site principal investigators by email. Respondents were asked about site practices pertaining to the use of temperature control, including the request to upload individual institutional protocols. Open-ended responses were analyzed qualitatively by categorizing responses into identified themes. To complement survey level data, records pertaining to the quality of temperature control were extracted from the ICECAP trial database.
The survey response rate was 75% (n = 51) including 23.5% (n = 12) survey respondents who uploaded institutional protocols. Most sites reported having institutional protocols for temperature control (n = 41; 80%), including 62.5% (n = 32) who had separate protocols for initiation of temperature control in the emergency department (ED). Fewer sites had protocols specific to sedation or neuromuscular blockade (NMB) management (n = 35, 68.6%). Use of NMB during temperature control induction was variable; 61.7% (n = 29) of sites induced paralysis less than 20% of the time. While most institutional protocols (n = 11, 83.3%) commented on the importance of early initiation of temperature control, this was incongruent with the largest reported barrier, which was clinical nihilism regarding the importance of early temperature control initiation (n = 30, 62.5%). Within the ICECAP trial database, 1 in 2 patients were treated with NMB however, use of NMB and time to initiation of temperature control device varied widely between sites.
Amongst ICECAP trial sites, there was significant variability in resources, methods, and barriers for early temperature control initiation. Defining and standardizing high-quality temperature control must be prioritized, as it may impact the interpretation of past and current clinical trial findings.
体温控制是一项复杂的捆绑式干预措施；每个单独组成部分的协同影响尚未明确且报道较少。因此，参数优化对体温控制整体神经保护效果的影响仍知之甚少。为了描述体温控制参数的变异性以及缩短诱导前和诱导时间的障碍，我们对正在参加正在进行的多中心临床试验的站点进行了调查。
这是一项横断面调查研究，评估了影响心脏骤停患者降温效果的持续时间（ICECAP）试验（NCT04217551）中体温控制实践。通过电子邮件向现场主要研究者分发了一个包含 23 个问题的基于网络的调查（Qualtrics）。受访者被要求回答有关体温控制使用的站点实践，包括要求上传个别机构方案。通过将回复分为已确定的主题来对开放式回复进行定性分析。为了补充调查数据，从 ICECAP 试验数据库中提取了与体温控制质量相关的记录。
调查回复率为 75%（n=51），其中 23.5%（n=12）的调查回复者上传了机构方案。大多数站点报告有体温控制的机构方案（n=41；80%），包括 62.5%（n=32）在急诊科（ED）有单独的方案用于开始体温控制。很少有站点有专门针对镇静或神经肌肉阻滞（NMB）管理的方案（n=35，68.6%）。在体温控制诱导期间使用 NMB 的情况各不相同；61.7%（n=29）的站点诱导麻痹的时间不到 20%。虽然大多数机构方案（n=11，83.3%）评论了早期开始体温控制的重要性，但这与最大报告的障碍不一致，该障碍是对早期体温控制开始的重要性的临床虚无主义（n=30，62.5%）。在 ICECAP 试验数据库中，每 2 名患者中就有 1 名接受了 NMB 治疗，但是，NMB 的使用和开始使用体温控制设备的时间在站点之间差异很大。
在 ICECAP 试验站点中，早期体温控制启动的资源、方法和障碍存在很大差异。必须优先确定和标准化高质量的体温控制，因为这可能会影响对过去和当前临床试验结果的解释。
