Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology

Conditions
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Complication of Surgical Procedure

Intervention / Treatment
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* Other: The New Safety Checklist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Safety Checklist<br>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. | Other: The New Safety Checklist<br>* 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.<br>|
| No Intervention: Habitual Practice<br>Patients randomized in this arm they will receive the habitual practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INCIDENCE 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. | from the discharge or up to 24 hours post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | from the discharge or up to 24 hours post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing, Patient Safety, Checklist, Cardiology