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

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ClinicalTrials.gov Identifier: NCT02419053
Recruitment Status : Completed
First Posted : April 17, 2015
Last Update Posted : October 13, 2016
Sponsor:
Collaborator:
Institute for Clinical Evaluative Sciences
Information provided by (Responsible Party):
James O'Leary, The Hospital for Sick Children

Brief Summary:
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.

Condition or disease Intervention/treatment
Intraoperative Complications Postoperative Complications Other: Surgical Safety Checklist

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Study Type : Observational
Actual Enrollment : 28772 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children
Study Start Date : October 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Healthcare utilization - proportion of Emergency Room visits [ Time Frame: 30-days after surgery ]
    Number of Emergency Room visits

  2. Healthcare utilization - rate of unplanned return to the operating room [ Time Frame: 30-days after surgery ]
    Unplanned return to the operating room

  3. Healthcare utilization - length of hospital stay [ Time Frame: 30-days after surgery ]
    Length of hospital stay



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical interventions performed in Ontario for children
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419053


Locations
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Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Institute for Clinical Evaluative Sciences
Investigators
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Principal Investigator: James D O'Leary, MBBCh The Hospital for Sick Children, Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James O'Leary, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02419053     History of Changes
Other Study ID Numbers: 1000046196
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Keywords provided by James O'Leary, The Hospital for Sick Children:
Surgical safety checklist
perioperative complications
pediatric
Additional relevant MeSH terms:
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Postoperative Complications
Intraoperative Complications
Pathologic Processes