The hypothesis is that patients undergoing cardiac catheterization, in which the New Safety Checklist has been used, have fewer perioperative complications compared to patients in which the habitual practice has been used.
The aim of this study is to develop a New Safety Checklist in perioperative patients undergoing cardiac catheterization in interventional cardiology units and assess it impact on the incidence of perioperative complications compared to habitual practice. The study will consist in two phases; the first phase: development of the New Safety Checklist, and the second phase will be a multicenter randomized clinical trial, a parallel two-arm corresponding to the use of the New Safety Checklist compared to the habitual practice in all patients undergoing cardiac catheterization in interventional cardiology units, according to the inclusion criteria.. The expected number of patients in this trial will be 6000. The principal outcome of this study will be: the incidence of perioperative complications. The secondary outcomes will be: socio-demographic data, clinical patient data and procedure type data. Data collection will be done through reviewing clinical history.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
6,000
Patients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist.
FGS Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGINCIDENCE of PERIOPERATIVE COMPLICATIONS
The perioperative complications will be collected after randomization, from discharge or up to24 hours post-procedure. The clinical history will be reviewed to evaluate the incidence of complications. Expected complications will be: severe systemic complications (major cardiovascular events \[MACE\], coronary artery complications, and structural complications), peripheral vascular complications, and reactions to contrast media.
Time frame: from the discharge or up to 24 hours post-procedure
Socio-demographic data
Socio-demographic data will be collected after randomization, from the discharge or up to 24 hours post-procedure. The clinical history will be reviewed to collect socio-demographic data: gender (male/female), age (absolute value), weight (kilograms) and height (centimeters).
Time frame: from the discharge or up to 24 hours post-procedure
Clinical data
Clinical data will be collected after randomization, from the discharge or up to 24 hours post-procedure. The clinical history will be reviewed to collect cardiovascular risk factors (dyslipemia, smoking), clinical record (medical allergies, ischemic, valvular heart disease, cardiomyopathy, arrhythmias, disease pulmonary, platelet antiaggregant treatment).
Time frame: from the discharge or up to 24 hours post-procedure
Procedure data
Procedure data will be collected after randomization, from the discharge or up to 24 hours post-procedure. The clinical history will be reviewed to collect procedure data, tipe of procedure done (coronary, structural, diagnostic procedure, right catheterization).
Time frame: from the discharge or up to 24 hours post-procedure
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