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

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ClinicalTrials.gov Identifier: NCT03218176
Recruitment Status : Completed
First Posted : July 14, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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).

Condition or disease Intervention/treatment Phase
Hemorrhage Device: Proximal single upper limb Device: Proximal staggered upper limb Device: Distal single upper limb Device: Distal staggered upper limb Device: Proximal single lower limb Device: Proximal staggered lower limb Device: Distal single lower limb Device: Distal staggered lower limb Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : October 23, 2017
Actual Study Completion Date : October 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Proximal single upper limb
Laying a single tourniquet on the root of the upper limb
Device: Proximal single upper limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Experimental: 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
Device: Proximal staggered upper limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Experimental: Distal single upper limb
Laying a single tourniquet on the forearm
Device: Distal single upper limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Experimental: Distal staggered upper limb
Laying two staggered tourniquets : one on the forearm and a second 5 cm below the previous one
Device: Distal staggered upper limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Active Comparator: Proximal single lower limb
Laying a single tourniquet on the root of the lower limb
Device: Proximal single lower limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Experimental: 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
Device: Proximal staggered lower limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Experimental: Distal single lower limb
Laying a single tourniquet on the calf
Device: Distal single lower limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Experimental: Distal staggered lower limb
Laying two staggered tourniquets : one on the calf and a second 5 cm below the previous one
Device: Distal staggered lower limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218176


Locations
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France
CHU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Emilie Gelin, MD CHU de Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03218176    
Other Study ID Numbers: GARROTS (29BRC17.0087)
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes