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The primary objectives of this observational study are to demonstrate the benefits, safety and impact on care of using Terry2™ band in patients undergoing diagnostic or interventional catheterization by radial (or ulnar) approach.
Radial Artery Occlusion (RAO) is the most common peri-procedural complication after a trans-radial catheterization,
Although usually asymptomatic, RAO may prevent the use of radial artery access in future catheterization should the patient need one; the use And the artery cannot be used as an alternate graft in case the patient is referred for aorto-coronary bypass surgery.
Recent data has demonstrated a clinical benefit for the use of radial artery over a venous graft for patients requiring artery bypass grafts.
Current international recommendations suggest limiting the risk of RAO to less than 5% upon discharge from hospital. To do this a change of method, ie performing a non-occlusive hemostasis of the radial artery is the most effective method to limit the risk of RAO. Unfortunately, this method takes time and requires repeated interventions by nurses, which has limited its application worldwide. In addition, simple hemostasis systems (on radial artery alone) can only achieve non-occlusive hemostasis in 60-75% of cases.
On the other hand, it has been shown that by applying simultaneous pressure to the two arteries of the wrist (the radial artery and the cubital artery), one could obtain a non-occlusive hemostasis of the radial artery in more than 95% of cases and the level of RAO was reduced < 2%. However, the handling of 2 separate hemostasis systems again requires repeated intervention by the nursing staff and therefore burdens the monitoring procedure.
The device Terry2™ band applies simultaneous differential compression to the radial artery and the cubital artery. Its mechanism of action aims to accelerate the time of hemostasis, reduce nursing work, improve patient comfort and minimize the risk of radial artery occlusion during and after hemostasis.
Hypotheses:
Procedures:
At the end of the radial approach procedure, patients will have a Terry2 band installed™ according to the instructions for use. Staff will be trained on the use of the device by means of an educational video. Once the device is installed, a check for the presence of non-occlusive hemostasis will be done before the patient has returned to their room.
Once the hemostasis is completed, the permeability of the radial artery is again checked by pulse oximetry. In case of doubt about the permeability of the instrumented artery, it is recommended to validate with an ultrasound-doppler.
Rates of RAO and other access site complications, total nursing time involved and patient comfort will be evaluated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terry2 Band | Device | Hemostasis protocol following radial or cubital approach catheterization using the dual artery hemostasis device Terry2Band. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of radial artery occlusion | Rate of radial artery occlusion throughout hemostasis until hospital discharge as measured by oximetry (photoplethysmography PPG) . The absence of a PPG curve indicates radial artery occlusion. Inconclusive cases maybe confirmed by doppler echography. | 30 - 270 minutes after catheterization |
| Total time to hemostasis | Characterization of the total time required to obtain hemostasis of the access site after transradial catheterization using the Terry2 band. Measured from device installation until removal. | 30 - 270 minutes after catheterization or until hemostasis is achieved |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient comfort rating | Change on patient comfort/pain perception measured by a visual analog scale (VAS) before placing the device and after its removal. The VAS used ranges from 0 to 10, where the lower scores refer to lower pain and higher comfort. 0 -1 Very comfortable / No pain 2 -3 Comfortable / Mild pain 4 - 5 Somewhat comfortable / Moderate Pain 6 - 7 Somewhat uncomfortable / Severe Pain 8 - 9 Uncomfortable / Very severe pain 10- Very uncomfortable / Extreme pain |
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Inclusion Criteria:
Exclusion Criteria:
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All comer adult population referred for diagnostic or interventional catheterization by transradial or transcubital approach at the participant centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomas A Cieza Lara, MD | Contact | +1 481 6568711 | 4666 | tomas.cieza@criucpq.ulaval.ca |
| Michèle Jadin | Contact | michele.jadin@criucpq.ulaval.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CSSS Chicoutimi | Not yet recruiting | Chicoutimi | Quebec | G7H 5H6 | Canada |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| During procedure |
| Rate of access site complications | Using the EASY scale for hematoma and bleeding | up to 30 days after catheterization |
| Total nursing time involvement | Total nursing time dedicated to care for access site until hemostasis is achieved. Calculated as as a combination of the number of interventions and time per intervention. | During hemostasis up to 24 hours after catheterization. |
| CHUM- Centre hospitalier de l'Université de Montréal | Not yet recruiting | Montreal | Quebec | Canada |
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| CHU de Québec | Not yet recruiting | Québec | Quebec | Canada |
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| IUCPQ - Laval Hospital | Recruiting | Québec | Quebec | Canada |
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| Hôpital Sainte-Marie | Not yet recruiting | Trois-Rivières | Quebec | Canada |
|