四肢创伤骨科手术中的个性化止血带压力与统一止血带压力：前瞻性随机对照研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-10-26 DOI:10.1016/j.conctc.2024.101376

Zhi-jian Sun , Cheng-hui Chen , Zhe-lun Tan , Chang-run Li , Han Fei , Xiang Yu , Dong-chen Yao , Ting Li

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引用次数: 0

摘要

背景在骨科手术领域，止血带常用来获得清晰的手术视野、加快手术进程并最大限度地减少出血事件。然而，如何确定最佳止血带充气压力一直是个争论不休的话题。目前的方法是使用恒定的止血带压力，但这有可能增加止血带相关并发症的风险。外科技师协会建议上肢使用收缩压加 50 mm Hg 的止血带压力，下肢使用 100 mm Hg 的止血带压力。然而，这种方法缺乏高质量医学文献的有力支持。因此，本研究旨在比较根据收缩压设定止血带压力与使用恒压法设定止血带压力的止血效果和差异。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）。研究对象包括年龄在 16 岁至 70 岁之间、上下肢有新鲜骨折（不足 3 周）的患者。所有患者都需要进行手术治疗，包括术中使用止血带，并且没有手术禁忌症。我们的主要结果是评估外科医生对术野止血效果的满意度。我们还检查了使用止血带的肢体周长的变化，并跟踪了术后并发症及其发生率。讨论尽管止血带在与四肢骨折相关的外科手术中得到了普遍使用，但关于压力和其他因素的调整仍存在相互矛盾的观点。该研究旨在比较基于收缩压的止血带压力设置与恒压法止血带压力设置的止血效果和差异。研究注册该研究于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）。注册网站https://www.chictr.org.cn/showproj.aspx?proj=162504。

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Personalized tourniquet pressure versus uniform tourniquet pressure in orthopedic trauma surgery of extremities: A prospective randomized controlled study protocol

Background

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.

Discussion

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.

Study registration

The study was duly recorded in the Chinese Clinical Trial Registry on May 13, 2022 (Registration number: ChiCTR2200059867).

Registration website

https://www.chictr.org.cn/showproj.aspx?proj=162504.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.