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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 months study duration

First Submitted

Initial submission to the registry

July 10, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed

17 days until next milestone

Study Start

First participant enrolled

July 31, 2017

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2017

Completed

Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

July 10, 2017

Last Update Submit

October 31, 2017

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (2)

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 Outcomes (4)

Lower limb pain
10 min
Upper limb pressure under tourniquet
10 min
Pulse oximetry
10 min
Loss of arterial Doppler pulse
10 min

Study Arms (8)

Proximal single upper limb

ACTIVE COMPARATOR

Laying a single tourniquet on the root of the upper limb

Device: Proximal single upper limb

Proximal staggered upper limb

EXPERIMENTAL

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

Distal single upper limb

EXPERIMENTAL

Laying a single tourniquet on the forearm

Device: Distal single upper limb

Distal staggered upper limb

EXPERIMENTAL

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

Device: Distal staggered upper limb

Proximal single lower limb

ACTIVE COMPARATOR

Laying a single tourniquet on the root of the lower limb

Device: Proximal single lower limb

Proximal staggered lower limb

EXPERIMENTAL

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

Distal single lower limb

EXPERIMENTAL

Laying a single tourniquet on the calf

Device: Distal single lower limb

Distal staggered lower limb

EXPERIMENTAL

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

Device: Distal staggered lower limb