NCT04205825

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complication of Surgical Procedure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-02
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-12-20
• Last updated: 2019-12-20

Locations

1 site across 1 country: Spain