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

NCT02419053 | Completed

• 1 other identifier: 1000046196
• Study Type: observational
• Target: 28,772
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Complications; Postoperative Complications

Keywords

Surgical safety checklist; perioperative complications; pediatric

Outcome Measures

Primary Outcomes (1)

• Perioperative complications

  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 Outcomes (3)

• Healthcare utilization - proportion of Emergency Room visits

  30-days after surgery

• Healthcare utilization - rate of unplanned return to the operating room

  30-days after surgery

• Healthcare utilization - length of hospital stay

  30-days after surgery

Study Arms (2)

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

Interventions

Surgical Safety Checklist OTHER

An Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health

Post-checklist

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Surgical interventions performed in Ontario for children

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Institute for Clinical Evaluative Sciences: collaborator

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

• O'Leary JD, Wijeysundera DN, Crawford MW. Effect of surgical safety checklists on pediatric surgical complications in Ontario. CMAJ. 2016 Jun 14;188(9):E191-E198. doi: 10.1503/cmaj.151333. Epub 2016 Mar 14.

  PMID: 26976960 DERIVED

MeSH Terms

Conditions

Intraoperative Complications; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James D O'Leary, MBBCh

  The Hospital for Sick Children, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 17, 2015
• Study Start: October 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

CA (1)