Scoring System for Inhalation Injury

Inhalation Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194024
• Other study ID #: ABA-MCTG-0004
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Inhalation Injury
• Respiratory Aspiration
• Wounds and Injuries

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