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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

Tracking Information
First Submitted Date  ICMJE July 10, 2017
First Posted Date  ICMJE July 14, 2017
Last Update Posted Date November 1, 2017
Actual Study Start Date  ICMJE July 31, 2017
Actual Primary Completion Date October 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • 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.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tourniquets Type Combat Application Tourniquet: Proximal or Distal Location, Simple or Staggered on Upper and Lower Limb
Official Title  ICMJE Tourniquets Type Combat Application Tourniquet (CAT): Vascular Suffering According to the Proximal or Distal Location, Simple or Staggered. Study to Upper and Lower Limbs
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hemorrhage
Intervention  ICMJE
  • Device: Proximal single upper limb
    Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
  • Device: Proximal staggered upper limb
    Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
  • Device: Distal single upper limb
    Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
  • Device: Distal staggered upper limb
    Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
  • Device: Proximal single lower limb
    Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
  • Device: Proximal staggered lower limb
    Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
  • Device: Distal single lower limb
    Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
  • Device: Distal staggered lower limb
    Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
Study Arms  ICMJE
  • Active Comparator: Proximal single upper limb
    Laying a single tourniquet on the root of the upper limb
    Intervention: Device: Proximal single upper limb
  • 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
    Intervention: Device: Proximal staggered upper limb
  • Experimental: Distal single upper limb
    Laying a single tourniquet on the forearm
    Intervention: Device: Distal single upper limb
  • Experimental: Distal staggered upper limb
    Laying two staggered tourniquets : one on the forearm and a second 5 cm below the previous one
    Intervention: Device: Distal staggered upper limb
  • Active Comparator: Proximal single lower limb
    Laying a single tourniquet on the root of the lower limb
    Intervention: Device: Proximal single lower limb
  • 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
    Intervention: Device: Proximal staggered lower limb
  • Experimental: Distal single lower limb
    Laying a single tourniquet on the calf
    Intervention: Device: Distal single lower limb
  • Experimental: Distal staggered lower limb
    Laying two staggered tourniquets : one on the calf and a second 5 cm below the previous one
    Intervention: Device: Distal staggered lower limb
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 23, 2017
Actual Primary Completion Date October 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03218176
Other Study ID Numbers  ICMJE GARROTS (29BRC17.0087)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emilie Gelin, MD CHU de Brest
PRS Account University Hospital, Brest
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP