Scoring System for Inhalation Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01194024
Recruitment Status : Active, not recruiting
First Posted : September 2, 2010
Last Update Posted : December 12, 2016
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
American Burn Association

Brief Summary:
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

Condition or disease Intervention/treatment
Inhalation Injury Other: Standard of Care

Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Burn Multicenter Proposal: Development of an Inhalation Injury Scoring System to Predict Severity of Inhalation Injury
Study Start Date : November 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Biospecimen Retention:   Samples With DNA
bronchioalveolar lavage specimens, blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01194024

United States, Arizona
The Arizona Burn Center, Maricopa Integrated Health Systems
Phoenix, Arizona, United States, 85008
United States, Arkansas
Arkensas Children's Hopital
Little Rock, Arkansas, United States, 72202
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Illinois
Loyola University
Maywood, Illinois, United States, 60153
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Ohio
The Metro Health System
Cleveland, Ohio, United States, 44109
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38103
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
American Burn Association
U.S. Army Medical Research and Materiel Command
Principal Investigator: Kevin N. Foster, MD The Arizona burn Center, Maricopa Integrated Health Systems

Responsible Party: American Burn Association Identifier: NCT01194024     History of Changes
Other Study ID Numbers: ABA-MCTG-0004
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016

Keywords provided by American Burn Association:
Inhalation Injury, Smoke
Inhalation Injury, Acute

Additional relevant MeSH terms:
Wounds and Injuries
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes