Scoring System for Inhalation Injury

Completed

• Conditions: Inhalation Injury
• Interventions: Other: Standard of Care

• Registration Number: NCT01194024
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Study Start: 2011-11-30
• Primary Completion: 2019-09-29
• Study Completion: 2019-09-29
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intubated within 24hrs of admission	Standard of Care	All patients that are admitted to a participating burn center and intubated within 24 hours

Primary Outcome Measures

Name	Time	Method
Development of a diagnostic model to predict the severity of inhalation injury	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

Name	Time	Method
Impact of inhalation injury	at discharge	Assessment of the impact of inhalation injury on the incidence of pneumonia, acute respiratory distress syndrome (ARDS), and acute lung injury (ALI).

Trial Locations

Locations (9)

Arkensas Children's Hopital; 🇺🇸 Little Rock, Arkansas, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States

Loyola University; 🇺🇸 Maywood, Illinois, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

The Metro Health System; 🇺🇸 Cleveland, Ohio, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

The Arizona Burn Center, Maricopa Integrated Health Systems; 🇺🇸 Phoenix, Arizona, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States