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

NCT ID: NCT04329117

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

526 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-26

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Alfred I. duPont Hospital for Children

OTHER

Sponsor Role collaborator

Akron Children's Hospital

OTHER

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role collaborator

Le Bonheur Children's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital Colorado

OTHER

Sponsor Role collaborator

Nemours Children's Health System

OTHER

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph Cravero

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Cravero, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Boston Children's Hospital

Waltham, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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P00031812

Identifier Type: -

Identifier Source: org_study_id

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