Tourniquets Type Combat Application Tourniquet: Proximal or Distal Location, Simple or Staggered on Upper and Lower Limb - Clinical Trial for Hemorrhage | NCT03218176

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Proximal single upper limb

Proximal staggered upper limb

Distal single upper limb

Distal staggered upper limb

Proximal single lower limb

Proximal staggered lower limb

Distal single lower limb

Distal staggered lower limb

About this trial

This is an interventional other trial for Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU de Brest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Proximal single upper limb

Proximal staggered upper limb

Distal single upper limb

Distal staggered upper limb

Proximal single lower limb

Proximal staggered lower limb

Distal single lower limb

Distal staggered lower limb

Arm Description

Laying a single tourniquet on the root of the upper limb

Laying two staggered tourniquets : one on the root of the upper limb and a second 5 cm below the previous one

Laying a single tourniquet on the forearm

Laying two staggered tourniquets : one on the forearm and a second 5 cm below the previous one

Laying a single tourniquet on the root of the lower limb

Laying two staggered tourniquets : one on the root of the lower limb and a second 5 cm below the previous one

Laying a single tourniquet on the calf

Laying two staggered tourniquets : one on the calf and a second 5 cm below the previous one

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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

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.

Full Information

NCT ID

NCT03218176

First Posted

July 10, 2017

Last Updated

October 31, 2017

Sponsor

University Hospital, Brest

1. Study Identification

Unique Protocol Identification Number

NCT03218176

Brief Title

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

Acronym

GARROTS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

July 31, 2017 (Actual)

Primary Completion Date

October 23, 2017 (Actual)

Study Completion Date

October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhage

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proximal single upper limb

Arm Type

Active Comparator

Arm Description

Laying a single tourniquet on the root of the upper limb

Arm Title

Proximal staggered upper limb

Arm Type

Experimental

Arm Description

Laying two staggered tourniquets : one on the root of the upper limb and a second 5 cm below the previous one

Arm Title

Distal single upper limb

Arm Type

Experimental

Arm Description

Laying a single tourniquet on the forearm

Arm Title

Distal staggered upper limb

Arm Type

Experimental

Arm Description

Laying two staggered tourniquets : one on the forearm and a second 5 cm below the previous one

Arm Title

Proximal single lower limb

Arm Type

Active Comparator

Arm Description

Laying a single tourniquet on the root of the lower limb

Arm Title

Proximal staggered lower limb

Arm Type

Experimental

Arm Description

Laying two staggered tourniquets : one on the root of the lower limb and a second 5 cm below the previous one

Arm Title

Distal single lower limb

Arm Type

Experimental

Arm Description

Laying a single tourniquet on the calf

Arm Title

Distal staggered lower limb

Arm Type

Experimental

Arm Description

Laying two staggered tourniquets : one on the calf and a second 5 cm below the previous one

Intervention Type

Device

Intervention Name(s)

Proximal single upper limb

Intervention Description