Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology
NCT ID: NCT04205825
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6000 participants
INTERVENTIONAL
2019-12-02
2020-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
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.
Habitual Practice
Patients randomized in this arm they will receive the habitual practice.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients who accept to participate in the study.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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FGS Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIBSP-LVS-2017-49
Identifier Type: -
Identifier Source: org_study_id
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