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

NCT ID: NCT03218176

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2017-10-23

Brief Summary

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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

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Conditions

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Hemorrhage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Proximal single upper limb

Laying a single tourniquet on the root of the upper limb

Group Type ACTIVE_COMPARATOR

Proximal single upper limb

Intervention Type DEVICE

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

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

Group Type EXPERIMENTAL

Proximal staggered upper limb

Intervention Type DEVICE

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Distal single upper limb

Laying a single tourniquet on the forearm

Group Type EXPERIMENTAL

Distal single upper limb

Intervention Type DEVICE

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Distal staggered upper limb

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

Group Type EXPERIMENTAL

Distal staggered upper limb

Intervention Type DEVICE

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Proximal single lower limb

Laying a single tourniquet on the root of the lower limb

Group Type ACTIVE_COMPARATOR

Proximal single lower limb

Intervention Type DEVICE

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

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

Group Type EXPERIMENTAL

Proximal staggered lower limb

Intervention Type DEVICE

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Distal single lower limb

Laying a single tourniquet on the calf

Group Type EXPERIMENTAL

Distal single lower limb

Intervention Type DEVICE

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Distal staggered lower limb

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

Group Type EXPERIMENTAL

Distal staggered lower limb

Intervention Type DEVICE

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Interventions

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Proximal single upper limb

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Intervention Type DEVICE

Proximal staggered upper limb

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Intervention Type DEVICE

Distal single upper limb

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Intervention Type DEVICE

Distal staggered upper limb

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Intervention Type DEVICE

Proximal single lower limb

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Intervention Type DEVICE

Proximal staggered lower limb

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Intervention Type DEVICE

Distal single lower limb

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Intervention Type DEVICE

Distal staggered lower limb

Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie Gelin, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Brest

Locations

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CHU de Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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GARROTS (29BRC17.0087)

Identifier Type: -

Identifier Source: org_study_id