Safety Improvement and Checklist Application (SICA)

May 4, 2015 updated by: Matthias Bock, Regional Hospital of Bolzano

Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center

The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective surgery in general or regional anesthesia lasting > 15 min

Exclusion Criteria:

  • urgent surgery

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: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: before surgical checklist
ACTIVE_COMPARATOR: after implementation surgical checklist
Procedure: implementation surgical checklist
a checklist according to the suggestions raised by the WHO is implementated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of complications after elective surgery
Time Frame: within 30 days
comparison of number of complications in the two study arms before and after introduction of the checklist
within 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days
evaluation of 30-days mortality
30 days

Collaborators and Investigators

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

Sponsor

Regional Hospital of Bolzano

Investigators

  • Study Director: Matthias Bock, MD, Central Hospital Bolzano Italy

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

June 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

April 26, 2011

First Posted (ESTIMATE)

April 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • check4outcome2

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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