Inhalation InjuryNCT01194024
Scoring System for Inhalation Injury
An observational study of Inhalation Injury, run by American Burn Association at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inhalation Injury
- How many people
- 108 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Nov 2011to 29 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes all patients admitted to a participating burn center and who are intubated withing 24 hours of injury .
Who may be able to join
- 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
Who cannot join
- ≤ 17 years of age
- Prisoner
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
The Metro Health System
Cleveland, Ohio, 44109
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Indiana University
Indianapolis, Indiana, 46202
Arkensas Children's Hopital
Little Rock, Arkansas, 72202
Loyola University
Maywood, Illinois, 60153
University of Tennessee Health Science Center
Memphis, Tennessee, 38103
The Arizona Burn Center, Maricopa Integrated Health Systems
Phoenix, Arizona, 85008
University of California Davis Medical Center
Sacramento, California, 95817
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Burn Multicenter Proposal: Development of an Inhalation Injury Scoring System to Predict Severity of Inhalation Injury
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
Read the 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
- Conditions
- Inhalation Injury
- Being tested
- Standard of Care
- Keywords
- Inhalation Injury, Smoke, Inhalation Injury, Acute
- Medical subject headings
- Smoke Inhalation Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
bronchoscopy with collection of bronchioalveolar lavage specimen, blood samples, High-Resolution spiral computed tomography(CT)
| Study group | Role | What they receive |
|---|---|---|
| Intubated within 24hrs of admission | All patients that are admitted to a participating burn center and intubated within 24 hours Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a diagnostic model to predict the severity of inhalation injury
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.
Measured: within 48 hours of admission
Secondary outcomes (1)
Impact of inhalation injury
Assessment of the impact of inhalation injury on the incidence of pneumonia, acute respiratory distress syndrome (ARDS), and acute lung injury (ALI).
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study start30 Nov 2011
- Primary completion29 Sep 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inhalation InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Kevin N. Foster, MD, Principal investigator, The Arizona burn Center, Maricopa Integrated Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194024
- Sponsor's protocol ID
- ABA-MCTG-0004
- Status last verified
- Jul 2021
- First submitted
- 1 Sep 2010
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Ronkar NC, Galet C, Richey K, Foster K, Wibbenmeyer L. Predictors and Impact of Pneumonia on Adverse Outcomes in Inhalation Injury Patients. J Burn Care Res. 2023 Nov 2;44(6):1289-1297. doi: 10.1093/jbcr/irad099.
PubMed 37352120
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burn Multicenter Proposal: Development of an Inhalation Injury Scoring System to Predict Severity of Inhalation Injury
- ClinicalTrials.gov ID
- NCT01194024
- Acronym / sponsor ID
- ABA-MCTG-0004
- Conditions
- Inhalation Injury
- Keywords
- Inhalation Injury, Smoke, Inhalation Injury, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 30 Nov 2011 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated within 24hrs of admission | – | Other: Standard of CareAll patients that are admitted to a participating burn center and intubated within 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes all patients admitted to a participating burn center and who are intubated withing 24 hours of injury .
Key inclusion criteria (7 listed)
- Injury consistent with inhalation of smoke or products of combustion
- Requires intubation within 24 hours of injury
- Meets one of the following 4 criteria
Key exclusion criteria (2 listed)
- ≤ 17 years of age
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Carebronchoscopy with collection of bronchioalveolar lavage specimen, blood samples, High-Resolution spiral computed tomography(CT) | Other | Intubated within 24hrs of admission |
Primary outcome
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.
1 secondary outcome
Impact of inhalation injury
Time frame: at discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 37352120Ronkar NC, Galet C, Richey K, Foster K, Wibbenmeyer L. Predictors and Impact of Pneumonia on Adverse Outcomes in Inhalation Injury Patients. J Burn Care Res. 2023 Nov 2;44(6):1289-1297. doi: 10.1093/jbcr/irad099.
Related trials for Inhalation Injury
Active, not recruitingObservational study
Short- and Long-term Health Effects of Air Pollution in Poland
Acute Coronary Syndrome, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin N. Foster, MD principal investigator
The Arizona burn Center, Maricopa Integrated Health Systems
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inhalation Injury, run by American Burn Association at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a diagnostic model to predict the severity of inhalation injury (time frame: within 48 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01194024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021; AzTrials last refreshed its copy on 30 Oct 2026.