Measures of lower limb venous blood flow with Sequential Compression
Research type
Research Study
Full title
Haemodynamic Laboratory Clinical Evaluation Protocol For the Kendall SCD™ Sequential Compression System.
IRAS ID
208216
Contact name
MAURA B GRIFFIN
Contact email
Sponsor organisation
Covidien LP - subsidary of MEDTRONIC
Duration of Study in the UK
0 years, 7 months, 18 days
Research summary
The purpose of this prospective, non-invasive haemodynamic laboratory clinical evaluation is, (a) to determine the optimum IPC compression pressure required for subjects with varying leg measurements and (b) to determine whether the combined use of the Kendall SCD™ Sequential Compressions System and T.E.D. anti-embolism stockings affect the optimum compression pressure for subjects with varying leg measurements.
The device inflates sequentially three chambers, typically ankle, calf and thigh which are referred to generically as Bladder 1, Bladder 2 and Bladder 3 respectively, in a sleeve applied to the legs. Total compression period is 11 seconds. Inflation first starts in Bladder 1 (time 0). Inflation of Bladder 2 starts at 2.5 sec and in Bladder 3 at 5.5 seconds. Peak pressure in Bladder 2 is 5 mmHg less than pressure in Bladder 1 and peak pressure in Bladder 3 is 10mmHg less than Bladder 2. Thus, at any time in the compression period, pressure in a proximal chamber is always lower than the adjacent distal chamber.
During the study, the peak pressure in Bladder 1 will be varied from 25 to 65 mm Hg with the pressure difference of 10 and 5 mmHg maintained in the more proximal chambers. Peak Velocity (PV), Total Volume Flow (TVF), and Refill Time (RT) in the right common femoral vein will be measured noninvasively using duplex ultrasound. The laboratory assessment will be comprised of two parts and involve 42 healthy volunteers. PART I will be a pilot study in 6 healthy volunteers for pressure range finding and determination of the effect of TED elastic stockings on PV, TVF and RT. Results from PHASE I will be used to refine the range of compression pressures in PHASE II. PHASE II will represent the main study in 36 healthy volunteers.REC name
London - Stanmore Research Ethics Committee
REC reference
16/LO/1541
Date of REC Opinion
9 Sep 2016
REC opinion
Favourable Opinion