Scoring System for Inhalation Injury

This study is enrolling participants by invitation only.
Sponsor:
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: July 16, 2013
Last verified: July 2013
  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

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38103
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: July 16, 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
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014