Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: VenAir, SCD700.
- Кому может быть актуально
- Состояния в реестре: No Condition, Healthy Individuals, No Conditions, Aged 20-64. Базовые параметры: 20 лет — 64 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this clinical trial is to learn an Intermittent Pneumatic Compression Device (IPCD), VenAir, effectiveness in healthy adults. The main questions this research aims to answer are: 1. The hemodynamic performance of VenAir paired with the thigh garments, calf garments, and foot garments is not inferior to that of SCD700 paired with the corresponding garments. 2. The hemodynamic performance of VenAir paired with the thigh garments, calf garments, and foot garments is not inferior to that of SCD700 paired with the thigh garment. Researchers will compare VenAir and the SCD700 to see if the hemodynamic performance of VenAir is as well as or not worse than the SCD700. Participants will lie down and rest for approximately 30 minutes to stabilize their heart rate. The researcher will then use ultrasound to measure the participant's blood flow while they wear different leg garments (one at a time) and also when no garment is worn.
Вмешательства
- Устройство VenAir
VenAir is an intermittent pneumatic compression (IPC) device intended to help prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In this study, VenAir is applied to the participant's lower limb under standard operating settings, and hemodynamic performance is measured for comparison with SCD700. - Устройство SCD700
SCD700 is a commercially available intermittent pneumatic compression (IPC) device used to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In this study, SCD700 is applied to the participant's lower limb under standard operating settings, and hemodynamic performance is measured to compare with VenAir.
Первичные конечные точки
- Peak Velocity of Blood Flow Increasement [Срок оценки: During and immediately after device application]
Критерии участия
Критерии включения
- Healthy adults
- Aged 20-64 years
- Leg circumference within the size range of the SCD700 and VenAir garments
Критерии исключения
- Cardiovascular-related diseases (mild atherosclerosis, other ischemic vascular diseases, congestive heart failure, etc.)
- Previous suspicion of deep vein thrombosis, pulmonary embolism, or phlebitis
- History of stroke
- History of varicose vein surgery
- Hypertension
- Diabetes
- Dermatitis, gangrene, or severe wounds
- Massive edema of legs
- Pregnancy
- Pulmonary edema
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Тайвань · 1 центр
- Wellell Inc. — New Taipei City
Публикации
- Muhe E. Intermittent sequential high-pressure compression of the leg. A new method of preventing deep vein thrombosis. Am J Surg. 1984 Jun;147(6):781-5. doi: 10.1016/0002-9610(84)90200-9. PMID 6731693
- Kamm R, Butcher R, Froelich J, Johnson M, Salzman E, Shapiro A, Strauss HW. Optimisation of indices of external pneumatic compression for prophylaxis against deep vein thrombosis: radionuclide gated imaging studies. Cardiovasc Res. 1986 Aug;20(8):588-96. doi: 10.1093/cvr/20.8.588. PMID 3791348
- Labropoulos N, Giuliano KK, Tafur AJ, Caprini JA. Comparison of a nonpneumatic device to four currently available intermittent pneumatic compression devices on common femoral blood flow dynamics. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1241-1247. doi: 10.1016/j.jvsv.2021.01.008. Epub 2021 Feb 1. PMID 33540132
- 1. Virchow RLK. Die Verstopfung den Lungenarterie und ihre Folgen. Beitr Exper Path Physiol. 1846;2(1). 2. Pavon JM, Adam SS, Razouki ZA, et al. Effectiveness of Intermittent Pneumatic Compression Devices for Venous Thromboembolism Prophylaxis in High-Risk Surgical Patients: A Systematic Review. J Arthroplasty. 2016;31(2):524-532. doi:10.1016/j.arth.2015.09.043 3. Anderson DR, Morgano GP, Bennett
- Kakkos SK, Szendro G, Griffin M, Sabetai MM, Nicolaides AN. Improved hemodynamic effectiveness and associated clinical correlations of a new intermittent pneumatic compression system in patients with chronic venous insufficiency. J Vasc Surg. 2001 Nov;34(5):915-22. doi: 10.1067/mva.2001.118822. PMID 11700495
- Kakkos SK, Szendro G, Griffin M, Daskalopoulou SS, Nicolaides AN. The efficacy of the new SCD response compression system in the prevention of venous stasis. J Vasc Surg. 2000 Nov;32(5):932-40. doi: 10.1067/mva.2000.110358. PMID 11054225
- Sadaghianloo N, Dardik A. The efficacy of intermittent pneumatic compression in the prevention of lower extremity deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2016 Apr;4(2):248-56. doi: 10.1016/j.jvsv.2015.07.006. Epub 2015 Sep 15. PMID 26993875
- Reitsma PH, Versteeg HH, Middeldorp S. Mechanistic view of risk factors for venous thromboembolism. Arterioscler Thromb Vasc Biol. 2012 Mar;32(3):563-8. doi: 10.1161/ATVBAHA.111.242818. PMID 22345594
Идентификаторы
NCT: NCT07287007 · EC1140707-F