Scoring System for Inhalation Injury

• ClinicalTrials.gov Identifier: NCT01194024
• Recruitment Status: Active, not recruiting
• First Posted: September 2, 2010
• Last Update Posted: April 22, 2020
• Sponsor: American Burn Association
• 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

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

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

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