NCT01194024

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 30, 2011

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2019

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

7.8 years

First QC Date

September 1, 2010

Last Update Submit

July 19, 2021

Conditions

Inhalation Injury

Keywords

Inhalation Injury, SmokeInhalation Injury, Acute

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 48 hours of admission

Secondary Outcomes (1)

  • Impact of inhalation injury

    at discharge

Study Arms (1)

Intubated within 24hrs of admission

All patients that are admitted to a participating burn center and intubated within 24 hours

Other: Standard of Care

Interventions

Standard of CareOTHER

bronchoscopy with collection of bronchioalveolar lavage specimen, blood samples, High-Resolution spiral computed tomography(CT)

Intubated within 24hrs of admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population includes all patients admitted to a participating burn center and who are intubated withing 24 hours of injury .

You may qualify if:

  • 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

You may not qualify if:

  • ≤ 17 years of age
  • Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The Arizona Burn Center, Maricopa Integrated Health Systems

Phoenix, Arizona, 85008, United States

Location

Arkensas Children's Hopital

Little Rock, Arkansas, 72202, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Metro Health System

Cleveland, Ohio, 44109, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • 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.

    PMID: 37352120DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

bronchioalveolar lavage specimens, blood samples

MeSH Terms

Conditions

Smoke Inhalation Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Burns, InhalationBurnsWounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kevin N. Foster, MD

    The Arizona burn Center, Maricopa Integrated Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 2, 2010

Study Start

November 30, 2011

Primary Completion

September 29, 2019

Study Completion

September 29, 2019

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

US(9)