Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Checklist Application and Mortality

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Regional Hospital of Bolzano.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Matthias Bock, Regional Hospital of Bolzano
ClinicalTrials.gov Identifier:
NCT01356446
First received: May 16, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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").


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

Further study details as provided by Regional Hospital of Bolzano:

Primary Outcome Measures:
  • Change in over all mortality [ Time Frame: within 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change in over all mortality [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]

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 implemented
Active Comparator: after implementation surgical checklist Procedure: implementation surgical checklist
a checklist according to the suggestions raised by the WHO is implemented

  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 / emergent 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: NCT01356446

Locations
Italy
Bolzano Central Hospital Recruiting
Bolzano, Italy, 39100
Contact: Matthias Bock, MD    00390471 ext 908673    matthias.bock@asbz.it   
Sponsors and Collaborators
Regional Hospital of Bolzano
Investigators
Principal Investigator: Matthias Bock, MD Central Hospital Bolzano, Italy
  More Information

No publications provided

Responsible Party: Matthias Bock, Impact of the Surgical Checklist on 30-day and 90-day Mortality in Elective Non-cardiac Surgery, Regional Hospital of Bolzano
ClinicalTrials.gov Identifier: NCT01356446     History of Changes
Other Study ID Numbers: check4outcome3
Study First Received: May 16, 2011
Last Updated: December 22, 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