Comparing different tourniquet models for limb hemorrhage control
Evaluation of the Arterial Occlusion Effect on Upper and Lower Limbs by the Application of Different Pre-hospital Tourniquet Models.
This study is testing different types of tourniquets to see which ones work best for stopping bleeding in arms and legs, using health students as volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Ribeirão Preto, Sao Paulo) |
| Trial ID | NCT06725602 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and mechanical properties of various commercially available pre-hospital tourniquet models on both upper and lower limbs. The study will involve 40 volunteer participants, primarily health-related students, who will undergo randomized application of tourniquets in a controlled environment. The trial will assess the occlusive capability of the tourniquets and validate techniques recommended in international guidelines for hemorrhage control. The methodology includes a cross-sectional design with blinding of the statistical analyst to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18 to 60 with a normal to overweight BMI and no significant medical history affecting limb vascularity.
Not a fit: Patients with conditions such as diabetes, hypertension, or recent limb injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance pre-hospital hemorrhage control techniques, potentially saving lives in trauma situations.
How similar studies have performed: While there have been studies on tourniquet effectiveness, this specific comparison of different models in a controlled setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Where this trial is running
Ribeirão Preto, Sao Paulo
- Ribeirão Preto Medical School USP (FMRP-USP), Experimental Surgery Department — Ribeirão Preto, Sao Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Roger W F Ronconi, PT, MSc, PhD(c) — Faculdade de Medicina de Ribeirão Preto da USP (FMRP-USP)
- Study coordinator: Roger W F Ronconi, PT, MSc, PhD(c)
- Email: rogerronconi@usp.br
- Phone: +5512991581359
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.