Radial Artery
Conditions
Keywords
Haemostasis, Trans radial band, Coronary angiography, Radial artery occlusion, Percutaneous coronary intervention
Brief summary
After performing a radial angiography/percutaneous coronary intervention (CAG/PCI), the sheath is removed and a compression device is used to achieve hemostasis. Recent studies have indicated that rapid deflation techniques resulting in early removal of the compression device is associated with a low incidence of radial artery occlusion (RAO). The purpose of the present study is to evaluate whether an even faster removal of the compression device can be achieved if using oximetry guided rapid deflation compared to traditional rapid deflation, and whether this is associated with a lower incidence of RAO.
Detailed description
3600 patients are randomized 1:1 to a traditional rapid deflation technique (Group A) versus an oximetry guided rapid deflation technique (Group B). Before randomisation between the two deflation techniques French size of the sheath is chosen. If the operator has a preference for the size of the sheath then this size is used (5F/6F, estimated N=1200). If the operator has no preference for the size of the sheath then patients are randomized between 5 and 6 French sheath (N=2400). Randomization between traditional rapid deflation technique (Group A) versus oximetry guided rapid deflation technique (Group B) is then stratified according to French size of the sheath used (5 French, 6 French). Terumo Glidesheath Slender is routinely used in both arms. Assuming that the incidence of RAO (Barbeau type D, see below) can be reduced from 1.5% to 0.5% a total of 1547 patients are needed in each group if using an alfa=0.05 and beta 0.80. Assuming that the incidence of RAO or subocclusion (Barbeau type C or D, see below) can be reduced from 4% to 2% a total of 1141 patients are needed in each group to document this difference if using an alfa=0.05 and beta 0.80. The investigators plan to randomize 1800 in each group comparing oximetry guided rapid deflation with traditional rapid deflation. Assuming that the time from sheath removal to transradial-band (TR-band) removal (hemostasis) is 125 minutes with the traditional rapid deflation technique, and 110 minutes with the oximetry guided deflation technique, and the standard deviation is 60 minutes, then a total number of 253 patients are needed in each group to document a possible difference. Data are analyzed by the intention-to-treat principle. 4-5 centres are expected to include patients. Oral and written informed consent is collected at the ward or in the Cath.lab. The informed consent is signed before intervention. Included patient can withdraw their assignment from the study at any time without consequence
Interventions
PROCEDUREOximetry guided deflation
At the cath.lab. (Step 1) a hemostasis test is performed: oxymetry device on the thumb, compress a.ulnaris, evaluate if curve on device (=Patent hemostasis). If patent no further action. If not patent, air is deflated until a.radialis is patent (curve on device and no bleeding). If bleeding occurs before patency then re-inflate 1-2 ml. air until hemostasis (=no patent hemostasis). In patients with Patent hemostasis no action is taken in sixty minutes whereafter the TR-band is fully deflated (Step 2), and if bleeding then air is re-inflated until hemostasis and step 2 is repeated every 20 minutes until the TR-band is fully deflated with hemostasis. If no patent hemostasis at cath.lab. a hemostasis test is performed after 20 min. If patent hemostasis is achieved no action is taken in sixy minutes (as above). If still not patent then further action as in group A.
Sponsors
Terumo Corporation
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who are scheduled for radial angiography or angioplasty. * Patients with normal flow in a.ulnaris before the procedure (Barbeau type A or B). * Age \> 18 years. * Patients able to cooperate and understand information given by the hospital staff.
Exclusion criteria
* Patients not able to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RAO (Reverse Barbeau type D) during index hospitalisation | Day 1 (Evaluated at time of TR-band removal) | The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery. |
| Time from sheath removal to removal of the TR-band | Day 1 | The time period will be recorded in the cath. lab. and in the ward. |
| Proportion who have the TR-band removed within 90,120 and 180 minutes | Day 1 | Calculated with STATA, statistical software |
| RAO (Reverse Barbeau type D) at follow-up | After 1 month | The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RAO or subocclusion during index hospitalisation | Day 1 (Evaluated at time of TR-band removal) | Evaluated by reverse Barbeau Test (type C+D) were a test result A is an open artery and D is a occluded artery and hence B + C are a subocclusion. |
| RAO or subocclusion at follow-up | At 1 month | Evaluated by reverse Barbeau Test (type C+D) were a test result A is an open artery and D is a occluded artery and hence B + C are a subocclusion. |
| Hematoma > 2.5 cm | Day 1 (Evaluated at time of discharge) | Development of hematoma is monitored at the ward at time of discharge. |
| Time from sheath removal to discharge | Day 1 | The discharge time is recorded in the patient file |
| Discomfort in the arm | At 1 month and 3 months | The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 (no pain) to 10 (worst possible pain) |
Countries
Denmark
Outcome results
None listed