跳至主要内容
临床试验/NCT06007209
NCT06007209进行中(未招募)不适用

Study Protocol: a Randomized Crossover Controlled Human Volunteer Trial Comparing Blind Manual Vs. Ultrasound-guided Pressure Point in Combat Medics

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
66
试验地点
1
主要终点
cumulative flow time

研究概览

简要总结

the goal of this clinical trial is to compare the effectiveness of manual pressure points (femoral and supra-clavicular) for hemorrhage control by military medics using either the traditional blind manual technique or an ultrasound guided technique in healthy human volunteers. The main question to answer is which technique provides better results with regard to cumulative flow cessation during a 180 seconds attempt.

Participants will press on each other's supraclavicular and femoral pressure points, twice each, once with an ultrasound probe and once with their hand, while distal flow is measured using ultrasound doppler.

详细描述

Each experimental day will include a maximum of 30 male subjects. Following the signing of an informed consent form and a questionnaire detailing possible exclusion criteria, subjects' demographics including age, gender, weight and height will be recorded. Right- or left-hand dominance, as well as the duration of service and previous training in MPP, will be determined by questioning and documented. This will be performed in a separate setting, ensuring subjects' privacy.

Then, all participants will undergo hands-on training in small groups concerning the pressure point technique - both blind application and ultrasound-guided application of the technique. Each participant will have the opportunity to try each technique at least once at each point.

Following the training session, participants will serve as both providers and models based on convenience (the order in which they approach the enrollment station), with each provider ideally becoming the subject for the next provider, although not necessarily. Each subject (medic) will perform two sets of attempts for pressure points application, on the same side of the model subject, which will be randomly determined (to avoid a bias created by the convenience of approach correseponding with providers' hand dominance). Before each set, the model subject's blood pressure and heart rate will be measured (on the contralateral side to the pressure application) and recorded. Each set will consist of three 180 seconds long attempts. Each attempt will be performed at a different point: Supraclavicular and femoral, with at least 120 seconds break between attempts. One of the sets will be performed using the blind, manual technique, using the provider's hands, and the other sets will be done using an ultrasound device guiding the location, direction and amount of pressure and using the probe itself to exert the pressure. The order in which the sets will be performed will be randomly determined.

At any point, any of the subjects can stop and end the attempt due to discomfort or any other reason. His participation will cease immediately, without the need for an explanation or taking any steps on his part. In that case, the same attempt (e.g. blind supraclavicular pressure) will not be repeated. However, this will not preclude the subject from participating in the following attempts as long as he is willing to.

At the end of each attempt, both the model and provider will be requested to rate their level of discomfort between 0 and 10 (NRS - Numerical Rating Score) During each attempt (including a 10-second baseline recording before each attempt), a sonographer will use a second ultrasound device to monitor blood flow distal to the pressure point using pulse-wave doppler. The sonographer will be blinded to the pressure technique used by the participant using a fabric blind and noise-cancelling headphones. The sonographer will vocally declare each time occlusion has been achieved or lost. A member of the experiment team will use a stopwatch to measure the total time of flow within each 180 seconds attempt. In addition, screen recording of the ultrasound device screen will be performed to allow for retrospective flow rate analysis using image analysis software. Screen recording of the pressing ultrasound screen will also be performed for potential retrospective analysis. Following each attempt, the cross-sectional area and mean flow rate of the artery in the intended pressure location will be measured by a sonographer to determine baseline flow through the artery, and clips will be collected to map the anatomy of the area for possible future analysis. This will be done after the attempt so that no markings will be left to guide the providers in their attempt.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Sonographer will be masked from the pressure technique used with a fabric blind and noise-cancelling headphones.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

cumulative flow time

时间窗: 180 seconds

The primary outcome for each attempt will be the cumulative flow time as a percentage of the 180 seconds attempt time.

次要结局

  • cumulative flow(180 seconds)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Barak Cohen, MD

Tel-Aviv Sourasky Medical Center

Tel-Aviv Sourasky Medical Center

研究点 (1)

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