Personalized tourniquet pressure versus uniform tourniquet pressure in orthopedic trauma surgery of extremities: A prospective randomized controlled study protocol
{"title":"Personalized tourniquet pressure versus uniform tourniquet pressure in orthopedic trauma surgery of extremities: A prospective randomized controlled study protocol","authors":"","doi":"10.1016/j.conctc.2024.101376","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods/design</h3><div>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.</div></div><div><h3>Discussion</h3><div>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.</div></div><div><h3>Study registration</h3><div>The study was duly recorded in the Chinese Clinical Trial Registry on May 13, 2022 (Registration number: ChiCTR2200059867).</div></div><div><h3>Registration website</h3><div><span><span>https://www.chictr.org.cn/showproj.aspx?proj=162504</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424001236","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
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).
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.