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

Not Applicable

• Conditions: Complication of Surgical Procedure

• Registration Number: NCT04205825
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-02
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-17
• Last Update Submitted: 2019-12-17
• Study First Posted: 2019-12-20
• Last Update Posted: 2019-12-20
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (1)

FGS Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain