Sun Zhi-Jian, Chen Cheng-Hui, Tan Zhe-Lun, Li Chang-Run, Fei Han, Yu Xiang, Yao Dong-Chen, Li Ting
Department of Orthopedic Trauma, Beijing Jishuitan Hospital Affiliated to Capital Medical University, No.31 Xin Jie Kou East Street, Xi Cheng District, Beijing, 100035, China.
Peking University Health Science Center, No.38 Xueyuan Road, Haidian District, Beijing, 100191, China.
Contemp Clin Trials Commun. 2024 Oct 26;42:101376. doi: 10.1016/j.conctc.2024.101376. eCollection 2024 Dec.
In the field of orthopedic surgery, tourniquets are often used to achieve a clear operative field, expedite operations, and minimize hemorrhagic events. However, determining the optimal tourniquet inflation pressure is a topic of debate. The current approach involves using a constant tourniquet pressure, although this is associated with the potential to augment the risk of tourniquet-associated complications. The Association of Surgical Technologists recommends a tourniquet pressure of systolic blood pressure plus 50 mm Hg for the upper limb and 100 mm Hg for the lower limb. Nevertheless, this method lacks robust support from high-quality medical literature. Therefore, the study aimed to compare the hemostatic efficacy and disparities in tourniquet pressure settings based on systolic blood pressure versus those using the constant-pressure method. The findings might outline the theoretical framework necessary for advocating for tourniquet pressure setups guided by systolic blood pressure.
METHODS/DESIGN: This randomized controlled study classified the tourniquet pressure regimen into two groups: one based on the patient's systolic blood pressure (the study group) and the other using a constant pressure (the control group). The study included patients aged between 16 and 70 who presented with fresh fractures (less than 3 weeks) of the lower and upper limbs. All the included patients required surgical treatment involving the intraoperative use of a tourniquet and had no contraindications to this surgery. Our primary outcome was to assess the surgeon's satisfaction with the hemostasis achieved in the operative field. We also examined the changes in the circumference of the limb where the tourniquet was applied and tracked any postoperative complications and their incidence. The study ultimately encompassed 144 patients.
Despite the prevalent use of tourniquets in surgical operations related to limb fractures, conflicting viewpoints persist concerning the adjustments in pressure and other elements. The study aimed to compare the hemostatic efficacy and disparities in tourniquet pressure settings based on systolic blood pressure versus those using the constant-pressure method.
The study was duly recorded in the Chinese Clinical Trial Registry on May 13, 2022 (Registration number: ChiCTR2200059867).
在骨科手术领域，止血带常被用于获得清晰的手术视野、加快手术进程并减少出血事件。然而，确定最佳止血带充气压力是一个存在争议的话题。目前的方法是使用恒定的止血带压力，尽管这可能会增加与止血带相关并发症的风险。外科技术人员协会建议上肢止血带压力为收缩压加50毫米汞柱，下肢为100毫米汞柱。然而，这种方法缺乏高质量医学文献的有力支持。因此，本研究旨在比较基于收缩压的止血带压力设置与使用恒定压力方法的止血效果及差异。研究结果可能会勾勒出倡导以收缩压为指导设置止血带压力所需的理论框架。
方法/设计：这项随机对照研究将止血带压力方案分为两组：一组基于患者的收缩压（研究组），另一组使用恒定压力（对照组）。该研究纳入了年龄在16至70岁之间、上下肢出现新鲜骨折（少于3周）的患者。所有纳入患者均需要进行涉及术中使用止血带的手术治疗，且无该手术的禁忌证。我们的主要结局是评估外科医生对手术视野止血效果的满意度。我们还检查了应用止血带肢体的周长变化，并追踪任何术后并发症及其发生率。该研究最终纳入了144例患者。
尽管止血带在与肢体骨折相关的外科手术中普遍使用，但关于压力调整和其他因素仍存在相互矛盾的观点。本研究旨在比较基于收缩压的止血带压力设置与使用恒定压力方法的止血效果及差异。
该研究于2022年5月13日在中国临床试验注册中心正式注册（注册号：ChiCTR2200059867）。
