Checklist Application and Mortality

Mortality Clinical Trial

Official title:

Impact of the Surgical Checklist on 30-day and 90-day Mortality in Elective Non-cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01356446
• Other study ID #: check4outcome3
• Status: Withdrawn
• Phase: N/A
• First received: May 16, 2011
• Last updated: May 4, 2015
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: Regional Hospital of Bolzano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The study investigates the impact of the implementation of a surgical checklist on the mortality 30 days and 90 days after surgery. Patients scheduled for elective surgical procedures (excluding cardiac surgery) lasting at least 15 minutes are eligible. Surgery is performed in a single tertiary care center. The study is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• urgent / emergent surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mortality
• Outcome

Intervention

Procedure:
• implementation surgical checklist
a checklist according to the suggestions raised by the WHO is implemented

Locations

Country	Name	City	State
Italy	Bolzano Central Hospital	Bolzano

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital of Bolzano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in over all mortality		within 90 days	Yes
Secondary	change in over all mortality		within 30 days	Yes