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Completed

NCT Number: NCT03218176

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

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).

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proximal single upper limb

Device

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

Proximal staggered upper limb

Device

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

Distal single upper limb

Device

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

Distal staggered upper limb

Device

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

Proximal single lower limb

Device

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

Proximal staggered lower limb

Device

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

Distal single lower limb

Device

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

Distal staggered lower limb

Device

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

Primary outcomes

  1. Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression

    Time frame: 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.

  2. Lower limb : Pressure (mmHg) needed to abolish the pulse

    Time frame: 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.

Secondary outcomes

  1. Lower limb pain

    Time frame: 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.

  2. Upper limb pressure under tourniquet

    Time frame: 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.

  3. Pulse oximetry

    Time frame: 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

  4. Loss of arterial Doppler pulse

    Time frame: 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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

Acronym: GARROTS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2017
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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