Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
During percutaneous coronary interventions standard operator radio-protection is generally ensured using a lead apron, a thyroid lead collar, low leaded flaps, an upper mobile leaded glass suspended from the ceiling and leaded glasses. Previous studies showed that adding a bismuth-barium radiation shield drape on the patient right arm or using a pelvic lead shield on the patient, the radiation dose adsorbed by operators was significantly reduced even if was higher compared to transfemoral approach. No studies evaluated the effect of both adjunctive shields placed in the same patient.
Aim of our randomized study is to evaluate if the combination of a shield drape on the patient right arm and a pelvic lead shield during transradial percutaneous coronary procedures may reduce the radiation dose adsorbed by operators compared to the use of only one shield or none.
All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study. Eligible patients will be randomized (using a computer generated randomization sequence) in 4 groups:
Each operator will be equipped with dedicated dosimeters placed at left wrist and at thorax level outside the lead apron. Since December 2013 the operators are equipped with a further dosimeter at head level.
Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters.
Secondary end-point are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic drape | Experimental | Pelvic shield drape over the patient |
|
| Arm drape | Experimental | Right radial arm drape over the patient |
|
| Pelvic and arm drape | Experimental | Pelvic and arm drpaes placed over the patient |
|
| No drapes | Sham Comparator | Standard radioprotection devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary angiography | Procedure | Diagnostic coronary angiography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose adsorbed by operators | Primary end-point of the study is the radiation dose adsorbed at wrist and thorax by operators and detected by the electronic dosimeters | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose adsorbed by operators according to the radial access (right versus left) | Radiation dose adsorbed by operators according to the radial access (right versus left) | During procedure |
| Radiation dose adsorbed by the patients |
Not provided
Inclusion Criteria:
All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this randomized study
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Sandro Pertini - ASL RMB- UOSD Emodinamica | Rome | Rome | Italy |
Not provided
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PCI | Procedure | Percutaneous coronary intervention |
|
| Right approach | Procedure | Right transradial access |
|
| Left approach | Procedure | Left transradial access |
|
Radiation dose adsorbed by the patients
| During procedure |