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

Completed

• Conditions: Postoperative Complications; Intraoperative Complications
• Interventions: Other: Surgical Safety Checklist

• Registration Number: NCT02419053
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-17
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28772

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-checklist	Surgical Safety Checklist	Surgical interventions performed for children after the introduction of the surgical safety checklist in Ontario, from October 2010 to September 2011.

Primary Outcome Measures

Name	Time	Method
Perioperative complications	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

Name	Time	Method
Healthcare utilization - proportion of Emergency Room visits	30-days after surgery	Number of Emergency Room visits
Healthcare utilization - rate of unplanned return to the operating room	30-days after surgery	Unplanned return to the operating room
Healthcare utilization - length of hospital stay	30-days after surgery	Length of hospital stay

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada