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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014