Tourniquets Type Combat Application Tourniquet: Proximal or Distal Location, Simple or Staggered on Upper and Lower Limb

Not Applicable

Completed

• Conditions: Hemorrhage
• Interventions: Device: Proximal single lower limb; Device: Distal single lower limb; Device: Proximal staggered upper limb; Device: Proximal single upper limb; Device: Distal single upper limb; Device: Distal staggered upper limb; Device: Proximal staggered lower limb; Device: Distal staggered lower limb

• Registration Number: NCT03218176
• Lead Sponsor: University Hospital, Brest

Brief Summary

A tourniquet is used to stop abundant bleeding when simple compression is not effective. The investigators will study the vascular suffering of the tourniquets according to their location on the limb: limb (arm / thigh) or distal (forearm / leg). Vascular suffering will be evaluated by the loss of the radial doppler flux for the tourniquets placed on the upper limb and in the tibial anterior to the lower limb by the loss of the pulse oximetry pulse and the collection of the signs described by the volunteers (pain, Paresthesia, cold sensation).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-14
• Study Start: 2017-07-31
• Status Verified: 2017-10
• Primary Completion: 2017-10-23
• Study Completion: 2017-10-23
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age greater than or equal to 18 years (major)
• Volunteer to participate in research

Exclusion Criteria

• Age less than 18 years
• Known coagulation disorder
• Known vascular disorder
• Known neurological disorder of the limbs
• Known muscle disorders of the limbs
• Presence of an implant in one of the limbs (vascular, contraceptive ...)
• Simultaneous participation in research involving anticoagulant therapy
• History of phlebitis
• Persons of full age who are subject to legal protection (safeguard of justice, person placed in curatorship, guardianship), persons deprived of their liberty.
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Proximal single lower limb	Proximal single lower limb	Laying a single tourniquet on the root of the lower limb
Distal single lower limb	Distal single lower limb	Laying a single tourniquet on the calf
Proximal staggered upper limb	Proximal staggered upper limb	Laying two staggered tourniquets : one on the root of the upper limb and a second 5 cm below the previous one
Proximal single upper limb	Proximal single upper limb	Laying a single tourniquet on the root of the upper limb
Distal single upper limb	Distal single upper limb	Laying a single tourniquet on the forearm
Distal staggered upper limb	Distal staggered upper limb	Laying two staggered tourniquets : one on the forearm and a second 5 cm below the previous one
Proximal staggered lower limb	Proximal staggered lower limb	Laying two staggered tourniquets : one on the root of the lower limb and a second 5 cm below the previous one
Distal staggered lower limb	Distal staggered lower limb	Laying two staggered tourniquets : one on the calf and a second 5 cm below the previous one

Primary Outcome Measures

Name	Time	Method
Lower limb : Pressure (mmHg) needed to abolish the pulse	10 min	The main evaluation criterion for the inferior member is the pressure under the tourniquet, necessary to obtain an abolition of the anterior tibial pulse (measured in Doppler). By means of a balloon connected to a pressure gauge and fixed under each tourniquet, a measure of the pressure exerted (in mmHg) by the tourniquet (s) on the skin will be measured at laying. The comparison will be made for each type of pose (single vs stage) between the proximal and distal layers.
Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression	10 min	The main evaluation criterion for the superior member is the assessment of the pain felt according to the location of the tourniquets at the time of laying and at 10min. For the same location of tourniquet, the pain caused by the laying of one versus two tourniquets will be compared. For proximal versus distal, comparisons will be made for 1 tourniquet and for staggered tourniquets.

Secondary Outcome Measures

Name	Time	Method
Pulse oximetry	10 min	Evaluation of the loss of the pulse oximetry, by a pulse oximeter placed on the finger or the toe, according to each mode of pose
Lower limb pain	10 min	The pain will be relieved according to the Digital Scale at the time of the raising of the tourniquets and at 10 minutes. For the same location of tourniquet, the pain caused by the laying of one versus two tourniquets will be compared. For proximal versus distal, comparisons will be made for 1 tourniquet and for staggered tourniquets.
Upper limb pressure under tourniquet	10 min	By means of a balloon connected to a pressure gauge and fixed under each tourniquet, a measure of the pressure exerted (in mmHg) by the tourniquet (s) on the skin will be measured at laying. The comparison will be made for each type of pose (single vs staggered) between the proximal and distal layers.
Loss of arterial Doppler pulse	10 min	The loss of the Doppler signal on the radial artery for the upper limbs and on the tibial anterior artery for the lower limbs will be evaluated for each type of poses to confirm arterial occlusion for each type of pose.

Trial Locations

Locations (1)

CHU de Brest; 🇫🇷 Brest, France