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Clinical Trials/NCT03218176
NCT03218176
Completed
Not Applicable

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

University Hospital, Brest1 site in 1 country30 target enrollmentJuly 31, 2017
ConditionsHemorrhage

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemorrhage
Sponsor
University Hospital, Brest
Enrollment
30
Locations
1
Primary Endpoint
Lower limb : Pressure (mmHg) needed to abolish the pulse
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 31, 2017
End Date
October 23, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

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

Study Sites (1)

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