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临床试验/NCT06725602
NCT06725602Enrolling By Invitation不适用

Evaluation of the Arterial Occlusion Effect on Upper and Lower Limbs by the Application of Different Pre-hospital Tourniquet Models.

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
2
主要终点
Arterial Occlusion (AO)

研究概览

简要总结

The goal of this clinical trial is to compare the occlusive capability and mechanical behavior of different commercially available pre-hospital tourniquet models and the results of their application on upper and lower limbs, in order to validate the techniques proposed in international guidelines regarding proximal application on the arm and thigh ("high and tight tourniquet") and controlled application, 2 to 3 inches proximally to the injury, on the forearm and leg ("controlled tourniquet").

It is estimated that 40 volunteer individuals will be recruited, who will sign the Informed Consent Form (ICF), a group primarily composed of undergraduate and graduate students in health-related fields. Regarding inclusion and exclusion criteria, these individuals will be of both sexes, aged ≥18 and ≤60 years, with both upper and lower limbs, a Body Mass Index (BMI) ≥18.5 and ≤30 kg/m² (considering the normal and overweight range, excluding underweight and obesity ranges), and without Diabetes Mellitus (DM), Systemic Arterial Hypertension, Buerger's disease, vascular and metabolic dysfunctions affecting the limbs including lymphedema, history of neoplasms, cardiac surgeries, renal failure, recent open or closed injuries in the limbs, or any other condition suggestive of systemic or localized vascular dysfunction in the limbs.

The main questions it aims to answer are:

Null Hypothesis (H0): There are no significant differences in the occlusive capability between TQs and in the efficacy of total vascular occlusion (arteriovenous) depending on the application site among the segments (forearm, arm, leg, thigh).

Alternative Hypothesis (H1): There are significant differences in the occlusive capability between TQs and in the efficacy of total vascular occlusion (arteriovenous) depending on the application site among the segments (forearm, arm, leg, thigh).

Specific Hypothesis: TQs will present significant variations in initial tightening pressures, arterial occlusion times, and arterial occlusion pressures, evidencing differences that may affect their efficacy.

Each participant will receive a total of 8 TQ applications on the arm, forearm, leg, and thigh segments bilaterally, for each of the 3 non-consecutive collection days. Vascular occlusion will be verified using Doppler ultrasound on the radial artery for upper limbs and on the posterior tibial artery for lower limbs.

It is a cross-sectional and self-controlled trial, aimed at collecting primary data, with randomization of the application order regarding device, laterality, segment, and blinding of the statistical analyst regarding the applied tourniquet model.

详细描述

METHOD

It is a cross-sectional and self-controlled trial, aimed at collecting primary data, with randomization of the application order regarding tourniquet unit, laterality, segment, and blinding of the statistical analyst regarding the applied tourniquet model.

Research Ethics

The research project was approved by the Research Ethics Committee of Hospital das Clínias, Ribeirão Preto Medical School, University of São Paulo (HCFMRP/USP), in accordance with Resolution with the Certificate of Ethical Appreciation (CAAE) number 79807023.9.0000.5440.

Volunteer Recruitment and Sample

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • have all four limbs (both upper and lower limbs)
  • Body Mass Index (BMI) ≥18.5 and ≤30 kg/m² (considering the normal and overweight range, excluding underweight and obesity ranges)

排除标准

  • Diabetes Mellitus (DM)
  • Systemic Arterial Hypertension
  • Buerger's Disease
  • Vascular and metabolic dysfunctions affecting the limbs including lymphedema
  • history of neoplasms
  • history of cardiac surgeries
  • history of renal failure
  • recent open or closed injuries in the limbs
  • any other condition suggestive of systemic or localized vascular dysfunction in the limbs.

结局指标

主要结局

Arterial Occlusion (AO)

时间窗: The measurements will be assessed after the volunteer has completed all 3 days of data collection, allowing for a comparison of the 3 study arms (TQ models).

Dichotomous variable indicated as POSITIVE (if it occurred) or NEGATIVE (if it did not occur). Variable measured immediately after the Tightening and Securing phase, in each application.

Arterial Occlusion Pressure (AOP)

时间窗: The measurements will be assessed after the volunteer has completed all 3 days of data collection, allowing for a comparison of the 3 study arms (TQ models).

Continuous variable, expressed in mmHg, corresponding to the pressure exerted by the TQ on the cuff, recorded at the confirmation of arterial occlusion after locking the device. It is measured immediately after the Tightening and Securing phase, in each TQ application.

次要结局

  • Initial Tightening Pressure (ITP)(The measures will be assessed after the volunteer has participated in all 3 days of data collection, to compare the 3 arms of the study (TQ models).)

研究者

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

Roger William Freire Ronconi

PhD Researcher

University of Sao Paulo

研究点 (2)

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