SICA: Safety Improvement and Checklist Application
Sponsor
Regional Hospital of Bolzano (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01343069
Collaborator
(none)
0
2
24
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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
Study Start Date
:
Jun 1, 2010
Anticipated Primary Completion Date
:
Jun 1, 2012
Anticipated Study Completion Date
:
Jun 1, 2012
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- number of complications after elective surgery [within 30 days]
comparison of number of complications in the two study arms before and after introduction of the checklist
Secondary Outcome Measures
- mortality [30 days]
evaluation of 30-days mortality
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- elective surgery in general or regional anesthesia lasting > 15 min
Exclusion Criteria:
- urgent surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Regional Hospital of Bolzano
Investigators
- Study Director: Matthias Bock, MD, Central Hospital Bolzano Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None 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
Other Study ID Numbers:
- check4outcome2
First Posted:
Apr 27, 2011
Last Update Posted:
May 5, 2015
Last Verified:
May 1, 2015
Keywords provided by 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