一项单中心、非盲、临床试验，比较健康人体应用止血带前后的血压：研究方案。
A single-center, nonblinded, clinical trial comparing blood pressures before and after tourniquet application in healthy humans: A study protocol.
机构信息
College of Medicine, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Department of Surgery, Medical University of South Carolina, Charleston, South Carolina, United States of America.
出版信息
PLoS One. 2023 Jan 6;18(1):e0280139. doi: 10.1371/journal.pone.0280139. eCollection 2023.
INTRODUCTION
Cardiac arrest is the leading cause of natural death in the United States, and most surviving patients suffer from neurological dysfunction. Although this is recognized as a problem, there have been very few changes to the cardiopulmonary resuscitation (CPR) procedure. Tourniquets have been recognized for their ability to increase truncal blood pressure and have been shown to improve CPR outcomes in animal models. However, the relationship between tourniquet application and blood pressure elevation has not been adequately explored in healthy human adults.
OBJECTIVES
The objective of this study is to demonstrate that bilateral, non-invasive, peripheral vascular occlusion in the thighs results in an increased proximal systolic blood pressure ≥ 10 mmHg.
METHODS
This is a single-center, non-blinded clinical trial. Volunteers will be screened for eligibility at least 24 hours before the day of the trial. On the day of the trial, volunteers will undergo an informed consent process. If they choose to participate in the trial after informed consent, their baseline blood pressure will be measured. Volunteers will then have a Combat Application Tourniquet (CAT) applied to each thigh, and the windlasses will be tightened by IRB-approved personnel. Once no pulse can be felt in the lower extremity, blood pressure will be measured in the arm. This will be replicated three times, and the tourniquets will be loosened between trials to allow the volunteers to rest. Any complications that arise during the trial will be handled by the physician that is present.
ANALYSIS
Changes in systolic blood pressure and diastolic blood pressure will be analyzed using a Shapiro-Wilk test. Then, a one-way repeated measures analysis of variance (ANOVA) will be performed with a Holm-Sidak post-hoc test to determine the mean differences. The significance level will be set to 5% for statistical significance.
REGISTRY AND REGISTRATION NUMBER
Clinicaltrials.gov, NCT05324306.
简介
在美国，心脏骤停是导致自然死亡的主要原因，大多数幸存的患者都有神经功能障碍。尽管这是一个公认的问题，但心肺复苏（CPR）程序几乎没有任何改变。止血带因其增加躯干血压的能力而得到认可，并已在动物模型中显示出可改善 CPR 结果。然而，在健康的成年人类中，止血带应用与血压升高之间的关系尚未得到充分探讨。
目的
本研究旨在证明双侧非侵入性大腿周围血管闭塞可导致近端收缩压升高≥10mmHg。
方法
这是一项单中心、非盲临床试验。志愿者将在试验前至少 24 小时进行资格筛选。在试验当天，志愿者将经历知情同意过程。如果他们在知情同意后选择参加试验，将测量他们的基础血压。然后将 Combat Application Tourniquet（CAT）应用于每条大腿，并且由 IRB 批准的人员收紧绞盘。一旦在下肢无法感觉到脉搏，就将测量手臂中的血压。这将重复三次，并且在每次试验之间松开止血带，让志愿者休息。在试验过程中出现的任何并发症将由在场的医生处理。
分析
将使用 Shapiro-Wilk 检验分析收缩压和舒张压的变化。然后，将使用单向重复测量方差分析（ANOVA）进行分析，并使用 Holm-Sidak 事后检验确定平均差异。统计显著性的显著水平将设置为 5%。
注册和注册号
Clinicaltrials.gov，NCT05324306。
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