Safety Improvement and Checklist Application (SICA)

This study has suspended participant recruitment.
(insufficient quality of data)
Sponsor:
Information provided by (Responsible Party):
Matthias Bock, Regional Hospital of Bolzano
ClinicalTrials.gov Identifier:
NCT01343069
First received: April 26, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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").


Condition Intervention
Complications
Outcome
Procedure: implementation surgical checklist

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center

Further study details as provided by Regional Hospital of Bolzano:

Primary Outcome Measures:
  • number of complications after elective surgery [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]
    comparison of number of complications in the two study arms before and after introduction of the checklist


Secondary Outcome Measures:
  • mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    evaluation of 30-days mortality


Estimated Enrollment: 4000
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: before surgical checklist Procedure: implementation surgical checklist
a checklist according to the suggestions raised by the WHO is implementated
Active Comparator: after implementation surgical checklist Procedure: implementation surgical checklist
a checklist according to the suggestions raised by the WHO is implementated

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • urgent surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343069

Sponsors and Collaborators
Regional Hospital of Bolzano
Investigators
Study Director: Matthias Bock, MD Central Hospital Bolzano Italy
  More Information

No publications provided

Responsible Party: Matthias Bock, Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center, Regional Hospital of Bolzano
ClinicalTrials.gov Identifier: NCT01343069     History of Changes
Other Study ID Numbers: check4outcome2
Study First Received: April 26, 2011
Last Updated: December 14, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Regional Hospital of Bolzano:
safety
team
team performance
surgery
outcome

ClinicalTrials.gov processed this record on April 21, 2014