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 : January 9, 2019
|
Sponsor:
American Burn Association
Collaborator:
U.S. Army Medical Research and Materiel 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 | 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 |
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 |
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 |
108 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
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 |
|
|||
PRS Account | American Burn Association | |||
Verification Date | June 2018 |