Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China.
Department of Urology, Huadong Hospital Affiliated to Fudan University, Shanghai, 200040, China.
Trials. 2024 Nov 19;25(1):780. doi: 10.1186/s13063-024-08628-2.
Performing spinal anesthesia in elderly patients with spine degeneration is challenging for novice practitioners. This stratified randomized controlled trial aims to compare the effectiveness of mixed reality-assisted spinal puncture (MRasp) with that of landmark-guided spinal puncture (LGsp) performed by novice practitioners in elderly patients.
This prospective, single-center, stratified, blocked, parallel randomized controlled trial will include 168 patients (aged ≥ 65 years) scheduled for elective surgery involving spinal anesthesia. All spinal punctures will be performed by anesthesiology interns and residents trained at Huadong Hospital. Patients will be randomly assigned to the MRasp group (n = 84) or the LGsp group (n = 84). Based on each intern/resident's experience in spinal puncture, participants will be stratified into three clusters: the primary group, intermediate group, and advanced group. The primary outcome will be the comparison of the rate of successful first-attempt needle insertion between the MRasp group and the LGsp group. Secondary outcomes will include the number of needle insertion attempts, the number of redirection attempts, the number of passes, the rate of successful first needle pass, the spinal puncture time, the total procedure time, and the incidence of perioperative complications. A stratified subgroup analysis will also be conducted for interns/residents at different experience levels.
The findings from this trial establish the effectiveness of MRasp by novice practitioners in elderly patients. This trial may provide experimental evidence for exploring an effective visualization technology to assist in spinal puncture.
Chinese Clinical Trials Registry ChiCTR2300075291. Registered on August 31, 2023. https://www.chictr.org.cn/bin/project/edit?pid=189622 .
在脊柱退变的老年患者中进行椎管内麻醉对新手从业者来说具有挑战性。本分层随机对照试验旨在比较混合现实辅助椎管内穿刺（MRasp）与新手从业者实施的基于体表标志的椎管内穿刺（LGsp）在老年患者中的效果。
这是一项前瞻性、单中心、分层、区组、平行随机对照试验，将纳入 168 名（年龄≥65 岁）拟行椎管内麻醉择期手术的患者。所有椎管内穿刺将由在华山医院接受培训的麻醉科住院医师和实习医生完成。患者将被随机分配至 MRasp 组（n=84）或 LGsp 组（n=84）。根据每位住院医师/实习医生的椎管内穿刺经验，参与者将被分层为三个亚组：初级组、中级组和高级组。主要结局是比较 MRasp 组和 LGsp 组首次尝试进针的成功率。次要结局包括进针次数、重新定向次数、穿刺次数、首次穿刺成功的比例、椎管内穿刺时间、总操作时间以及围手术期并发症的发生率。还将对不同经验水平的住院医师/实习医生进行分层亚组分析。
本试验确立了新手从业者在老年患者中应用 MRasp 的有效性。本试验可为探索有效的可视化技术辅助椎管内穿刺提供实验证据。
中国临床试验注册中心 ChiCTR2300075291。注册于 2023 年 8 月 31 日。https://www.chictr.org.cn/bin/project/edit?pid=189622。
