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

Hemorrhage Clinical Trial

— GARROTS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218176
• Other study ID #: GARROTS (29BRC17.0087)
• Status: Completed
• Phase: N/A
• First received: July 10, 2017
• Last updated: October 31, 2017
• Start date: July 31, 2017
• Est. completion date: October 23, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 23, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Device:
• Proximal single upper limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
• Proximal staggered upper limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
• Distal single upper limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
• Distal staggered upper limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
• Proximal single lower limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
• Proximal staggered lower limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
• Distal single lower limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
• Distal staggered lower limb
Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry

Locations

Country	Name	City	State
France	CHU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression	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.	10 min
Primary	Lower limb : Pressure (mmHg) needed to abolish the pulse	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.	10 min
Secondary	Lower limb pain	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.	10 min
Secondary	Upper limb pressure under tourniquet	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.	10 min
Secondary	Pulse oximetry	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	10 min
Secondary	Loss of arterial Doppler pulse	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.	10 min