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

December 17, 2019 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

6000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Adrian Marquez Lopez, RN. MsC. PhD student.
  • Phone Number: 7926 +342919000
  • Email: amarquez@santpau.cat

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • FGS Hospital de la Santa Creu i Sant Pau
        • Contact:
          • Adrian Marquez Lopez, RN. MsC. PhD student.
          • Phone Number: 7926 +349329100
          • Email: amarquez@santpau.cat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Habitual Practice
Patients randomized in this arm they will receive the habitual practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
INCIDENCE of PERIOPERATIVE COMPLICATIONS
Time Frame: from the discharge or up to 24 hours post-procedure

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographic data
Time Frame: from the discharge or up to 24 hours post-procedure

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
Clinical data
Time Frame: from the discharge or up to 24 hours post-procedure

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
Procedure data
Time Frame: from the discharge or up to 24 hours post-procedure

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIBSP-LVS-2017-49

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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