Performance of Junctional Tourniquets in Normal Human Volunteers

Phase 4

Completed

Brief Summary: Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.

Detailed Description: Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.

Recruitment & Eligibility

Inclusion Criteria

Adult human volunteers who are recruited, screened, and consent to participate
Ages at least 18 years old to no more than 60 years old (<61) on the date of consent
Male or female
A worker for the US Military or US Government (active duty military, civilian employees, contractors)

Exclusion Criteria

Active-duty military subjects without their supervisor's permission to participate
Detainees or prisoners
Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic disease diagnosis, stroke, peripheral vascular disease or dysfunction such as Reynaud's phenomenon, migraine headaches, or cardiovascular disease [uncontrolled hypertension, heart attack, or arrhythmias]), active abdominal, inguinal, gluteal, or thigh disease, major deformity, or hernias
Pregnancy
Contracted employees to the US Military or US Government without contractual permission to participate in the research

Arm && Interventions

Group	Intervention	Description
SJT	SJT	SAM Junctional Tourniquet
AAJT	AAJT	Use of Abdominal Aortic and Junctional Tourniquet
JETT	JETT	Junctional Emergency Treatment Tool
CRoC	CRoC	Use of Combat Ready Clamp (CRoC)

Primary Outcome Measures

Name	Time	Method
Effectiveness at Stopping Distal Pulse	1 min	Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.

Secondary Outcome Measures

Name	Time	Method
Pain During Tourniquet Application	1 minute	Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.