Scoring System for Inhalation Injury

Tracking Information
First Submitted Date	September 1, 2010
First Posted Date	September 2, 2010
Last Update Posted Date	January 9, 2019
Study Start Date	November 2011
Estimated Primary Completion Date	September 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: January 29, 2013)	Development of a diagnostic model to predict the severity of inhalation injury [ Time Frame: 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.
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01194024 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: January 29, 2013)	Impact of inhalation injury [ Time Frame: at discharge ]; Assessment of the impact of inhalation injury on the incidence of pneumonia, acute respiratory distress syndrome (ARDS), and acute lung injury (ALI).
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Scoring System for Inhalation Injury
Official Title	Burn Multicenter Proposal: Development of an Inhalation Injury Scoring System to Predict Severity of Inhalation Injury
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	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA; Description: bronchioalveolar lavage specimens, blood samples
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
Condition	Inhalation Injury
Intervention	Other: Standard of Care; bronchoscopy with collection of bronchioalveolar lavage specimen, blood samples, High-Resolution spiral computed tomography(CT)
Study Groups/Cohorts	Intubated within 24hrs of admission; All patients that are admitted to a participating burn center and intubated within 24 hours; Intervention: Other: Standard of Care
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Actual Enrollment; (submitted: December 8, 2016)	108
Original Estimated Enrollment; (submitted: September 1, 2010)	100
Estimated Study Completion Date	September 2019
Estimated Primary Completion Date	September 2019 (Final data collection date for primary outcome measure)
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 history of closed space injury carbonaceous sputum elevated carboxyhemoglobin dx of inhalation injury is considered likely by investigator Exclusion Criteria: ≤ 17 years of age; Prisoner
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01194024
Other Study ID Numbers	ABA-MCTG-0004
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	American Burn Association
Study Sponsor	American Burn Association
Collaborators	U.S. Army Medical Research and Materiel Command
Investigators	Principal Investigator: Kevin N. Foster, MD The Arizona burn Center, Maricopa Integrated Health Systems
PRS Account	American Burn Association
Verification Date	June 2018