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Checklist Application and Mortality

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Matthias Bock, Regional Hospital of Bolzano
ClinicalTrials.gov Identifier:
NCT01356446
First received: May 16, 2011
Last updated: May 4, 2015
Last verified: May 2015
  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
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 Matthias Bock, Regional Hospital of Bolzano:

Primary Outcome Measures:
  • Change in over all mortality [ Time Frame: within 90 days ]

Secondary Outcome Measures:
  • change in over all mortality [ Time Frame: within 30 days ]

Enrollment: 0
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
Active Comparator: after implementation surgical checklist Procedure: implementation surgical checklist
a checklist according to the suggestions raised by the WHO is implemented

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Bolzano, Italy, 39100
Sponsors and Collaborators
Regional Hospital of Bolzano
Investigators
Principal Investigator: Matthias Bock, MD Central Hospital Bolzano, Italy
  More Information

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: May 4, 2015

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

ClinicalTrials.gov processed this record on July 21, 2017