Scoring System for Inhalation Injury
This study is enrolling participants by invitation only.
Sponsor:
American Burn Association
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
American Burn Association
ClinicalTrials.gov Identifier:
NCT01194024
First received: September 1, 2010
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Inhalation Injury |
Other: Standard of Care |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Burn Multicenter Proposal: Development of an Inhalation Injury Scoring System to Predict Severity of Inhalation Injury |
Resource links provided by NLM:
Further study details as provided by American Burn Association:
Primary Outcome Measures:
- Development of a diagnostic model to predict the severity of inhalation injury [ Time Frame: within 48 hours of admission ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Impact of inhalation injury [ Time Frame: at discharge ] [ Designated as safety issue: No ]Assessment of the impact of inhalation injury on the incidence of pneumonia, acute respiratory distress syndrome (ARDS), and acute lung injury (ALI).
Biospecimen Retention: Samples With DNA
bronchioalveolar lavage specimens, blood samples
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Intubated within 24hrs of admission
All patients that are admitted to a participating burn center and intubated within 24 hours
|
Other: Standard of Care
bronchoscopy with collection of bronchioalveolar lavage specimen, blood samples, High-Resolution spiral computed tomography(CT)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194024
Locations
| United States, Arizona | |
| The Arizona Burn Center, Maricopa Integrated Health Systems | |
| Phoenix, Arizona, United States, 85008 | |
| United States, California | |
| University of California Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| United States, Illinois | |
| Loyola University | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
Sponsors and Collaborators
American Burn Association
U.S. Army Medical Research and Materiel Command
Investigators
| Principal Investigator: | Kevin N. Foster, MD | The Arizona burn Center, Maricopa Integrated Health Systems |
More Information
No publications provided
| Responsible Party: | American Burn Association |
| ClinicalTrials.gov Identifier: | NCT01194024 History of Changes |
| Other Study ID Numbers: | ABA-MCTG-0004 |
| Study First Received: | September 1, 2010 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by American Burn Association:
|
Inhalation Injury, Smoke Inhalation Injury, Acute |
Additional relevant MeSH terms:
|
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013