Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study

NCT ID: NCT05608460

Last Updated: 2022-11-08

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

UNKNOWN

Total Enrollment

15700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-15

Study Completion Date

2025-08-15

Brief Summary

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A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation.

Detailed Description

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Conditions

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Cervical Spine Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Any participant less than 18 years old after blunt trauma
* Seen by trauma service
* With cervical spine imaging (XR, CT, or MRI)

Exclusion Criteria

* CT scan from outside facility is poor quality and not repeated (\<63-channel, cuts \>3mm, no reformats, motion artifact)
* No radiology over reads by participating institution
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Katie Russell, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katie Russell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Rady Children's Hospital

San Diego, California, United States

Site Status NOT_YET_RECRUITING

UCSF Benioff Children's Hospital

San Francisco, California, United States

Site Status NOT_YET_RECRUITING

Lucile Packard Children's Hospital

Stanford, California, United States

Site Status NOT_YET_RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status NOT_YET_RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status NOT_YET_RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kezlyn Larsen, BS

Role: CONTACT

801-662-2989

Facility Contacts

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Melissa Nguyen

Role: primary

Laura Houshmand

Role: primary

Romeo Ignacio, MD

Role: primary

Aaron Jensen, MD

Role: primary

Rachelle Balili

Role: primary

Connor Prendergast

Role: primary

Andrew Mason

Role: primary

Maria Valencia

Role: primary

Kezlyn Larsen, BS

Role: primary

Other Identifiers

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C-Spine

Identifier Type: -

Identifier Source: org_study_id

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