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Scoring System for Inhalation Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01194024
Recruitment Status : Active, not recruiting
First Posted : September 2, 2010
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
American Burn Association

Tracking Information
First Submitted Date September 1, 2010
First Posted Date September 2, 2010
Last Update Posted Date April 22, 2020
Study Start Date November 2011
Estimated Primary Completion Date December 2020   (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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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 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 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 December 2020
Estimated Primary Completion Date December 2020   (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

    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
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 Development Command
Investigators
Principal Investigator: Kevin N. Foster, MD The Arizona burn Center, Maricopa Integrated Health Systems
PRS Account American Burn Association
Verification Date April 2020