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Efficacy of Prehospital Tourniquet Models for Arterial Occlusion in Upper and Lower Limbs

University of Sao Paulo · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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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
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