Division of Cardiovascular Sciences, The University of Manchester, Manchester, UK
Department of Accidents and Trauma, Prince Sultan bin Abdelaziz College for Emergency Medical Services, King Saud University, Riyadh, Saudi Arabia.
BMJ Open. 2024 Jun 11;14(6):e077191. doi: 10.1136/bmjopen-2023-077191.
Traumatic brain injury (TBI) is a common presentation in the prehospital environment. At present, paramedics do not routinely use tools to identify low-risk patients who could be left at scene or taken to a local hospital rather than a major trauma centre. The Canadian CT Head Rule (CCHR) was developed to guide the use of CT imaging in hospital. It has not been evaluated in the prehospital setting. We aim to address this gap by evaluating the feasibility and acceptability of implementing the CCHR to patients and paramedics, and the feasibility of conducting a full-scale clinical trial of its use.
We will recruit adult patients who are being transported to an emergency department (ED) by ambulance after suffering a mild TBI. Paramedics will prospectively collect data for the CCHR. All patients will be transported to the ED, where deferred consent will be taken and the treating clinician will reassess the CCHR, blinded to paramedic interpretation. The primary clinical outcome will be neurosurgically significant TBI. Feasibility outcomes include recruitment and attrition rates. We will assess acceptability of the CCHR to paramedics using the Ottawa Acceptability of Decision Rules Instrument. Interobserver reliability of the CCHR will be assessed between paramedics and the treating clinician in the ED. Participating paramedics and patients will be invited to participate in semistructured interviews to explore the acceptability of trial processes and facilitators and barriers to the use of the CCHR in practice. Data will be analysed thematically. We anticipate recruiting approximately 100 patients over 6 months.
This study was approved by the Health Research Authority and the Research Ethics Committee (REC reference: 22/NW/0358). The results will be published in a peer-reviewed journal, presented at conferences and will be incorporated into a doctoral thesis.
ISRCTN92566288.
创伤性脑损伤（TBI）是院前环境中的常见表现。目前，护理人员通常不使用工具来识别低风险患者，这些患者可以留在现场或送往当地医院，而不是送往主要创伤中心。加拿大 CT 头部规则（CCHR）是为指导医院使用 CT 成像而制定的。它尚未在院前环境中进行评估。我们旨在通过评估将 CCHR 实施到患者和护理人员中的可行性和可接受性，以及对其使用进行全面临床试验的可行性来解决这一差距。
我们将招募因轻度 TBI 而被救护车送往急诊科（ED）的成年患者。护理人员将前瞻性地为 CCHR 收集数据。所有患者都将被送往 ED，在那里将获得延迟同意，并由主治临床医生对 CCHR 进行重新评估，对护理人员的解释进行盲法评估。主要临床结局将是神经外科显著 TBI。可行性结局包括招募率和失访率。我们将使用渥太华决策规则接受度工具评估 CCHR 对护理人员的可接受性。ED 中的护理人员和主治临床医生之间将评估 CCHR 的观察者间可靠性。将邀请参与的护理人员和患者参加半结构化访谈，以探讨试验过程的可接受性以及 CCHR 在实践中使用的促进因素和障碍。数据将进行主题分析。我们预计在 6 个月内招募约 100 名患者。
这项研究得到了健康研究管理局和研究伦理委员会的批准（REC 参考：22/NW/0358）。结果将发表在同行评议的期刊上，在会议上展示，并将纳入博士论文。
ISRCTN92566288。
