Complication of Surgical Procedure
Conditions
Keywords
Nursing, Patient Safety, Checklist, Cardiology
Brief summary
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.
Detailed description
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.
Interventions
OTHERThe New Safety Checklist
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.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years) undergoing cardiological intervention in hemodynamic units and interventionist cardiology. * Patients who accept to participate in the study.
Exclusion criteria
* Patients undergoing urgent procedure. * Patients requiring ventilatory support or in a situation of hemodynamic instability. * Patients with cognitive impairment, mental disability or other serious difficulty in communication. * Patients with insufficient fluidity of the main languages.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| INCIDENCE of PERIOPERATIVE COMPLICATIONS | from the discharge or up to 24 hours post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Socio-demographic data | from the discharge or up to 24 hours post-procedure | 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). |
| Clinical data | from the discharge or up to 24 hours post-procedure | 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). |
| Procedure data | from the discharge or up to 24 hours post-procedure | 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). |
Countries
Spain
Contacts
Primary ContactAdrian Marquez Lopez, RN. MsC. PhD student.
Outcome results
None listed