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

Complication of Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04205825
• Other study ID #: IIBSP-LVS-2017-49
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Adrian Marquez Lopez, RN. MsC. PhD student.
• Phone: +342919000
• Email: amarquez[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication of Surgical Procedure

Intervention

Other:
• The 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.

Locations

Country	Name	City	State
Spain	FGS Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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