Complication of Surgical Procedure Clinical Trial
Official title:
Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology
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.
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.
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