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

Tourniquets Type Combat Application Tourniquet (CAT): Vascular Suffering According to the Proximal or Distal Location, Simple or Staggered. Study to Upper and Lower Limbs

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).

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Device: Proximal single upper limb; Device: Proximal staggered upper limb; Device: Distal single upper limb; Device: Distal staggered upper limb; Device: Proximal single lower limb; Device: Proximal staggered lower limb; Device: Distal single lower limb; Device: Distal staggered lower limb

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proximal single upper limb; Laying a single tourniquet on the root of the upper limb	Device: Proximal single upper limb; Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Experimental: 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	Device: Proximal staggered upper limb; Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Experimental: Distal single upper limb; Laying a single tourniquet on the forearm	Device: Distal single upper limb; Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Experimental: Distal staggered upper limb; Laying two staggered tourniquets : one on the forearm and a second 5 cm below the previous one	Device: Distal staggered upper limb; Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Active Comparator: Proximal single lower limb; Laying a single tourniquet on the root of the lower limb	Device: Proximal single lower limb; Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Experimental: 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	Device: Proximal staggered lower limb; Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Experimental: Distal single lower limb; Laying a single tourniquet on the calf	Device: Distal single lower limb; Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Experimental: Distal staggered lower limb; Laying two staggered tourniquets : one on the calf and a second 5 cm below the previous one	Device: Distal staggered lower limb; Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression	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.	10 min
Lower limb : Pressure (mmHg) needed to abolish the pulse	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.	10 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower limb pain	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.	10 min
Upper limb pressure under tourniquet	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.	10 min
Pulse oximetry	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	10 min
Loss of arterial Doppler pulse	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.	10 min

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Emilie Gelin, MD, CHU de Brest

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): October 23, 2017
• Study Completion (Actual): October 23, 2017

Study Registration Dates

• First Submitted: July 10, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: GARROTS (29BRC17.0087)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No