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

Study ID
STU 082011-062

Cancer Related

Healthy Volunteers

Study Sites

  • Parkland Health & Hospital System

Peter Gales

Principal Investigator
Steven Wolf, M.D.


This project will take place in one phase which will take three years to complete:
This study will be conducted at the arizona Burn Center, uC-Davis Regional Burn
Center, and approximately 3 other regional burn centers. The DCC will act as the
primary site coordinator for this study and will do collective analysis of all data from
individual sites. in addition, the arizona Burn Center will have access to all collected
data and final statistical analysis review.
Participating centers will achieve consensus on what methodology will be used to
diagnose inhalation injury (bronchoscopy, chest x-ray, etc) and on laboratory
parameters/biomarkers that will be assessed prospectively. This will standardize the
assessment and diagnosis of inhalation injury.
each participating center will use the standardized assessment and diagnostic
techniques described to assess 100 patients (20-25 at each site). Charts will be
reviewed for a series of parameters, as outlined in Baseline Data Collection and
Monitoring section below.
one broncheoaveolar lavage specimen and one blood sample will be collected on all
patients within 6-24 hours of injury (ideally 12 hours) for inflammatory marker testing. all
participating centers will send samples to a central testing lab for analysis.

The primary outcome measure will be the development of a diagnostic model to predict
the severity of inhalation injury based on the following independent variables:
demographics, characteristics of injury, bronchoscopy, CT scan, and inflammatory

Secondary outcomes include assessments of the impact of inhalation injury on the
incidence of pneumonia, aRDS and aLi. Further secondary studies will be performed at
the behest of participating centers

Participant Eligibility

Subject has an injury consistent with inhalation of smoke or products of combustion
Subject requires intubation within 24 hours of injury
Meets one of the following 4 criteria
Subject has a history of closed space injury
Subject has carbonaceous sputum
Subject has elevated carboxyhemoglobin
Clinical diagnosis of inhalation injury is considered likely by the investigator