Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children

October 12, 2016 updated by: James O'Leary, The Hospital for Sick Children
The purpose of this study is to see if the surgical safety checklist is associated with a reduction in perioperative complications for children undergoing surgery in Ontario, Canada.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28772

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgical interventions performed in Ontario for children

Description

Inclusion Criteria:

  • Surgical admission, with a noncardiac surgical interventions
  • Aged between >28 days and <18years on the day of the surgical intervention

Exclusion Criteria:

  • Non-surgical admission
  • Surgical interventions with <10 per group
  • Cardio-thoracic and interventional cardiology procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-checklist
Surgical interventions performed for children before the introduction of the surgical safety checklist in Ontario, from October 2008 to September 2009.
Post-checklist
Surgical interventions performed for children after the introduction of the surgical safety checklist in Ontario, from October 2010 to September 2011.
Other: Surgical Safety Checklist
An Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative complications
Time Frame: 30-days after surgery
Composite outcome, complications included were death (all-causes), acute renal failure, cardiac arrest, complications of implants or grafts, decubitus ulcer, deep vein thrombosis, disruption of wound, electrolyte or acid-base abnormality, hemorrhage or hematoma, pulmonary embolism, pulmonary collapse or pneumonia, surgical site infection, sepsis, shock, stroke, and vascular graft failure
30-days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare utilization - proportion of Emergency Room visits
Time Frame: 30-days after surgery
Number of Emergency Room visits
30-days after surgery
Healthcare utilization - rate of unplanned return to the operating room
Time Frame: 30-days after surgery
Unplanned return to the operating room
30-days after surgery
Healthcare utilization - length of hospital stay
Time Frame: 30-days after surgery
Length of hospital stay
30-days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Institute for Clinical Evaluative Sciences

Investigators

  • Principal Investigator: James D O'Leary, MBBCh, The Hospital for Sick Children, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000046196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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