BACKGROUND: Hemorrhage remains a leading cause of death in both civilian and military settings. Of preventable deaths from hemorrhage, a significant portion occurs from junctional wounds that are not amenable to traditional extremity tourniquets. Junctional tourniquets (JTQs) can potentially provide hemorrhage control by compressing the arteries at the junction of the trunk and extremities. The FDA has cleared 3 JTQ products: The Combat Ready Clamp (CRoC®), the Junctional Emergency Treatment Tool (JETT™), and the SAM® Junctional Tourniquet (SJT). However, little is known regarding which of these JTQs is superior in application time, effectiveness in pulse elimination, effectiveness during transport, and user preference. METHODS:Active duty corpsmen (N = 49) were given standardized instruction and hands-on training with the CRoC®, JETT™, and SJT, then sequentially applied each JTQ unilaterally to a fellow study participant in a randomized order. Pulse elimination was determined by Doppler ultrasound at the dorsalis pedis immediately then reevaluated after a short transport. User preference data were collected following testing. Data were analyzed using repeated measures ANOVA and non-parametric statistics at p < 0.05. RESULTS: The CRoC® was significantly slower in application time than the JETT™ and SJT. Effectiveness was similar for CRoC®, JETT™, and SJT. Effectiveness during transport was significantly higher for SJT than for the JETT™, but no JTQ performed well during transport (24-48% effectiveness). SJT ranked first in perceived ease of use, stability, and reliability, and in user trust and overall preference. Participants provided cogent suggestions for product improvement. CONCLUSIONS: All JTQ devices performed poorly during transport. Combined, present findings highlight the potential of JTQ products for saving lives threatened by junctional wounds, but also highlight the need for specific product improvements towards fostering JTQ performance in patient transport.
RCT Entities:
BACKGROUND:Hemorrhage remains a leading cause of death in both civilian and military settings. Of preventable deaths from hemorrhage, a significant portion occurs from junctional wounds that are not amenable to traditional extremity tourniquets. Junctional tourniquets (JTQs) can potentially provide hemorrhage control by compressing the arteries at the junction of the trunk and extremities. The FDA has cleared 3 JTQ products: The Combat Ready Clamp (CRoC®), the Junctional Emergency Treatment Tool (JETT™), and the SAM® Junctional Tourniquet (SJT). However, little is known regarding which of these JTQs is superior in application time, effectiveness in pulse elimination, effectiveness during transport, and user preference. METHODS: Active duty corpsmen (N = 49) were given standardized instruction and hands-on training with the CRoC®, JETT™, and SJT, then sequentially applied each JTQ unilaterally to a fellow study participant in a randomized order. Pulse elimination was determined by Doppler ultrasound at the dorsalis pedis immediately then reevaluated after a short transport. User preference data were collected following testing. Data were analyzed using repeated measures ANOVA and non-parametric statistics at p < 0.05. RESULTS: The CRoC® was significantly slower in application time than the JETT™ and SJT. Effectiveness was similar for CRoC®, JETT™, and SJT. Effectiveness during transport was significantly higher for SJT than for the JETT™, but no JTQ performed well during transport (24-48% effectiveness). SJT ranked first in perceived ease of use, stability, and reliability, and in user trust and overall preference. Participants provided cogent suggestions for product improvement. CONCLUSIONS: All JTQ devices performed poorly during transport. Combined, present findings highlight the potential of JTQ products for saving lives threatened by junctional wounds, but also highlight the need for specific product improvements towards fostering JTQ performance in patient transport.
Entities:
Keywords:
groin; hemorrhage; inguinal; medical device; resuscitation; tourniquets
Authors: Jhimli Mitra; Jianwei Qiu; Michael MacDonald; Prem Venugopal; Kirk Wallace; Hossam Abdou; Michael Richmond; Noha Elansary; Joseph Edwards; Neerav Patel; Jonathan Morrison; Luca Marinelli Journal: IEEE J Transl Eng Health Med Date: 2022-08-19