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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03218176
Acronym
GARROTS
Enrollment
30
Registered
2017-07-14
Start date
2017-07-31
Completion date
2017-10-23
Last updated
2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

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).

Interventions

DEVICEProximal single upper limb

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

DEVICEProximal staggered upper limb

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

DEVICEDistal single upper limb

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

DEVICEDistal staggered upper limb

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

DEVICEProximal single lower limb

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

DEVICEProximal staggered lower limb

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

DEVICEDistal single lower limb

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

DEVICEDistal staggered lower limb

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

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression10 minThe 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 pulse10 minThe 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

MeasureTime frameDescription
Lower limb pain10 minThe 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 tourniquet10 minBy 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 oximetry10 minEvaluation 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 pulse10 minThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026