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

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

Status: Unknown

Conditions: Complication of Surgical Procedure

Treatments: Other: The New Safety Checklist

Study type: Interventional

Funder types: Other

Identifiers

NCT04205825

IIBSP-LVS-2017-49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,000 participants in 2 patient groups

New Safety Checklist

Experimental group

Description:

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.

Treatment:

Other: The New Safety Checklist

Habitual Practice

No Intervention group

Description:

Patients randomized in this arm they will receive the habitual practice.