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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01194024
Other study ID # ABA-MCTG-0004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2011
Est. completion date September 29, 2019

Study information

Verified date July 2021
Source American Burn Association
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date September 29, 2019
Est. primary completion date September 29, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Standard of Care
bronchoscopy with collection of bronchioalveolar lavage specimen, blood samples, High-Resolution spiral computed tomography(CT)

Locations

Country Name City State
United States The Metro Health System Cleveland Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Indiana University Indianapolis Indiana
United States Arkensas Children's Hopital Little Rock Arkansas
United States Loyola University Maywood Illinois
United States University of Tennessee Health Science Center Memphis Tennessee
United States The Arizona Burn Center, Maricopa Integrated Health Systems Phoenix Arizona
United States University of California Davis Medical Center Sacramento California
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
American Burn Association U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Development of a diagnostic model to predict the severity of inhalation injury 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 Impact of inhalation injury Assessment of the impact of inhalation injury on the incidence of pneumonia, acute respiratory distress syndrome (ARDS), and acute lung injury (ALI). at discharge
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