Clinical trial NCT01194024: Scoring System for Inhalation Injury
Official title: Burn Multicenter Proposal: Development of an Inhalation Injury Scoring System to Predict Severity of Inhalation Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inhalation Injury
Keywords: Inhalation Injury, Smoke
Inhalation Injury, Acute
Lead sponsor: American Burn Association
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2010-09-02
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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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

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

Eligibility criteria: 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

Primary outcomes:
measure: Development of a diagnostic model to predict the severity of inhalation injury
timeFrame: within 48 hours of admission
Secondary outcomes:
measure: Impact of inhalation injury
timeFrame: at discharge
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The Arizona Burn Center, Maricopa Integrated Health Systems
state: Arizona
city: Little Rock
country: United States
facility: Arkensas Children's Hopital
state: Arkansas
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: The Metro Health System
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: The Arizona burn Center, Maricopa Integrated Health Systems
name: Kevin N. Foster, MD
role: PRINCIPAL_INVESTIGATOR
References: