Clinical trial NCT04329117: Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project
Official title: Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
name: Johns Hopkins University
name: Children's Hospital Medical Center, Cincinnati
name: Children's Hospital Los Angeles
name: University of Texas Southwestern Medical Center
name: Duke University
name: Alfred I. duPont Hospital for Children
name: Akron Children's Hospital
name: Children's National Health System
name: Le Bonheur Children's Hospital
name: Children's Hospital Colorado
name: Nemours Children's Health System
name: University of Texas at Austin
First posted: 2020-04-01
Enrollment: 526
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children undergoing scheduled surgical procedures on the anterior cruciate ligament in a hospital setting or surgical day center, aged 12-18 years old.

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.

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

Primary outcomes:
measure: Registry Creation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Waltham
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Joseph Cravero, MD
role: PRINCIPAL_INVESTIGATOR
References: