Scoring System for Inhalation Injury

July 19, 2021 updated by: American Burn Association

Burn Multicenter Proposal: Development of an Inhalation Injury Scoring System to Predict Severity of Inhalation Injury

The goal of this multicenter study is to develop a standardized scoring system for inhalation injury that can be used both to quantify and predict injury severity inhalation injury in adults over 18 years of age. A model will be developed based on clinical, radiographic, bronchoscopic, and biochemical parameters that will predict the severity of inhalation injury with greater than 80% predictive accuracy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this multicenter study is to develop a standardized scoring system for inhalation injury that can be used both to quantify and predict injury severity inhalation injury in adults over 18 years of age. A model will be developed based on clinical, radiographic, bronchoscopic, and biochemical parameters that will predict the severity of inhalation injury with greater than 80% predictive accuracy

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • The Arizona Burn Center, Maricopa Integrated Health Systems
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkensas Children's Hopital
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • The Metro Health System
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee Health Science Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population includes all patients admitted to a participating burn center and who are intubated withing 24 hours of injury

.

Description

Inclusion Criteria:

  • Injury consistent with inhalation of smoke or products of combustion
  • Requires intubation within 24 hours of injury

  • Meets one of the following 4 criteria

    1. history of closed space injury
    2. carbonaceous sputum
    3. elevated carboxyhemoglobin
    4. dx of inhalation injury is considered likely by investigator

Exclusion Criteria:

  • ≤ 17 years of age
  • Prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intubated within 24hrs of admission
All patients that are admitted to a participating burn center and intubated within 24 hours
Other: Standard of Care
bronchoscopy with collection of bronchioalveolar lavage specimen, blood samples, High-Resolution spiral computed tomography(CT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of a diagnostic model to predict the severity of inhalation injury
Time Frame: within 48 hours of admission
The development of a diagnostic model to predict the severity of inhalation injury based on demographics, characteristics of injury, bronchoscopy, CT scan, and inflammatory markers.
within 48 hours of admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of inhalation injury
Time Frame: at discharge
Assessment of the impact of inhalation injury on the incidence of pneumonia, acute respiratory distress syndrome (ARDS), and acute lung injury (ALI).
at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Burn Association

Collaborators

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Kevin N. Foster, MD, The Arizona Burn Center, Maricopa Integrated Health Systems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2011

Primary Completion (Actual)

September 29, 2019

Study Completion (Actual)

September 29, 2019

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABA-MCTG-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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