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Clinical Trials/NCT04329117
NCT04329117
Completed
Not Applicable

Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project

Boston Children's Hospital1 site in 1 country526 target enrollmentDecember 26, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Injuries
Sponsor
Boston Children's Hospital
Enrollment
526
Locations
1
Primary Endpoint
Registry Creation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The primary objective is to create a multicenter registry which captures information relating to the perioperative anesthesia course and management of children undergoing anterior cruciate ligament reconstruction and to examine practice patterns and incidence of complications. Data from any single institution involved in this registry will be used for local safety and quality improvement efforts. In addition data from each institution can be compared to the information from the entire group of institutions participating in the project, thus providing a measure for comparison with national practice. The aggregate multi-institutional data set will be used to develop quality benchmarks for national safety and quality improvement efforts and best practice recommendation. We believe that this registry can also demonstrate how web based data collection can be used to evaluate clinical anesthesia outcomes for surgeries with a low incidence of critical events but with significant variability in medical management.

Detailed Description

This multi institutional registry will capture data relating to perioperative practices and complications, some of which may be relatively infrequent. The goal of this group is to create this registry to be used for local safety and quality improvement and multi-center benchmarking in this population. Reports generated from the registry will provide individual institutions with comparative data showing how their site performs compared to composite averages from all participating sites. Queries of the composite data set may allow for identification of factors associated with improved outcomes in this population. Future queries of the data-base for research purposes will require approval of the participating members of SPAIN.

Registry
clinicaltrials.gov
Start Date
December 26, 2020
End Date
January 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Cravero

MD

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Males and females ages 12 years to 17.5 years
  • Patients undergoing scheduled surgical procedures on the anterior cruciate ligament construction surgery in a hospital setting or surgical day center.

Exclusion Criteria

  • Incarcerated subjects
  • Non-English speaking families and subjects

Outcomes

Primary Outcomes

Registry Creation

Time Frame: 2 years

The development of a multi-center registry of all anterior cruciate ligament reconstruction performed in the pediatric population with anterior cruciate ligament tear.

Study Sites (1)

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