NCT05705713

Brief Summary

A major risk factor for death in burn victims is inhalation lung injury. Diagnostic criteria and severity grading are not well understood. After an inhalation injury, the mucociliary escalator is impaired by induced mucosal hyperemia, which includes Edema, increased mucous production, and airway exudation, and these insults worsen airway narrowing which interferes with ventilation. Multimodal therapy and quick bronchoscopic diagnosis improve patient outcomes. Early identification and classification of inhalation injuries improve patient outcomes. Chest CT may be employed as an alternative to or supplement to the bronchoscopy as well as a diagnostic and prognostic tool. In this study, the diagnostic and prognostic value of bronchial wall thickening as a radiological CT finding in inhalation lung damage and the radiologist score (RADS) were evaluated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

December 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

January 20, 2023

Last Update Submit

January 30, 2023

Conditions

Inhalation Injury

Keywords

inhalation injuryBronchial wall thickeningRadiologist scorecomputed tomography.

Outcome Measures

Primary Outcomes (2)

  • bronchial wall thickening (BWT)

    measured through a CT chest scan at the end inspiration 2 cm distal to the tracheal bifurcation.

    24 hours

  • Radiologist score

    CT scans of each patient were examined using 1-cm axial slices from the apex to the diaphragm level. The right and left lung fields in each slice were subdivided into 4 quadrants. Each quadrant was awarded a score ranging from 0 to 3 based on the severity of the results. The highest score inside a quadrant was awarded as the final score, and a total score was produced for each slice. The total score for each slice was then added together for the full CT scan to get the RADS overall.

    24 hours

Study Arms (2)

Cases

EXPERIMENTAL

48 participants with burn injuries associated with inhalation lung injuries were recruited from the burn department.

Radiation: chest computed tomography (CT)

Control

ACTIVE COMPARATOR

10 participants with burn injuries NOT associated with inhalation lung injuries were recruited from the burn department.

Radiation: chest computed tomography (CT)

Interventions

chest computed tomography (CT)RADIATION

Within the first 12 hours of suspected inhalation lung injury, fiberoptic bronchoscopy was done to confirm the diagnosis. After confirming the diagnosis, an initial chest CT in the first 24 hrs through which the radiologist score (RADS) together with bronchial wall thickening (BWT) was done.

CasesControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any patient with a suspected inhalational lung injury

You may not qualify if:

  • less than 18 years old,
  • patients who had their CT scan after 24 hours after their admission
  • patients who couldn't finish all of the study steps.
  • patients that are known to have any parenchymal lung disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Latenser BA, Miller SF, Bessey PQ, Browning SM, Caruso DM, Gomez M, Jeng JC, Krichbaum JA, Lentz CW, Saffle JR, Schurr MJ, Greenhalgh DG, Kagan RJ. National Burn Repository 2006: a ten-year review. J Burn Care Res. 2007 Sep-Oct;28(5):635-58. doi: 10.1097/BCR.0B013E31814B25B1. No abstract available.

    PMID: 17969244BACKGROUND

  • Foncerrada G, Culnan DM, Capek KD, Gonzalez-Trejo S, Cambiaso-Daniel J, Woodson LC, Herndon DN, Finnerty CC, Lee JO. Inhalation Injury in the Burned Patient. Ann Plast Surg. 2018 Mar;80(3 Suppl 2):S98-S105. doi: 10.1097/SAP.0000000000001377.

    PMID: 29461292BACKGROUND

  • Kimura R, Traber LD, Herndon DN, Linares HA, Lubbesmeyer HJ, Traber DL. Increasing duration of smoke exposure induces more severe lung injury in sheep. J Appl Physiol (1985). 1988 Mar;64(3):1107-13. doi: 10.1152/jappl.1988.64.3.1107.

    PMID: 3366733BACKGROUND

  • Albright JM, Davis CS, Bird MD, Ramirez L, Kim H, Burnham EL, Gamelli RL, Kovacs EJ. The acute pulmonary inflammatory response to the graded severity of smoke inhalation injury. Crit Care Med. 2012 Apr;40(4):1113-21. doi: 10.1097/CCM.0b013e3182374a67.

    PMID: 22067627BACKGROUND

  • Hassan Z, Wong JK, Bush J, Bayat A, Dunn KW. Assessing the severity of inhalation injuries in adults. Burns. 2010 Mar;36(2):212-6. doi: 10.1016/j.burns.2009.06.205. Epub 2009 Dec 16.

    PMID: 20006445BACKGROUND

  • Oh JS, Chung KK, Allen A, Batchinsky AI, Huzar T, King BT, Wolf SE, Sjulin T, Cancio LC. Admission chest CT complements fiberoptic bronchoscopy in prediction of adverse outcomes in thermally injured patients. J Burn Care Res. 2012 Jul-Aug;33(4):532-8. doi: 10.1097/BCR.0b013e318237455f.

    PMID: 22210063BACKGROUND

  • Walker PF, Buehner MF, Wood LA, Boyer NL, Driscoll IR, Lundy JB, Cancio LC, Chung KK. Diagnosis and management of inhalation injury: an updated review. Crit Care. 2015 Oct 28;19:351. doi: 10.1186/s13054-015-1077-4.

    PMID: 26507130BACKGROUND

  • Yamamura H, Kaga S, Kaneda K, Mizobata Y. Chest computed tomography performed on admission helps predict the severity of smoke-inhalation injury. Crit Care. 2013 May 25;17(3):R95. doi: 10.1186/cc12740.

    PMID: 23706091BACKGROUND

  • Charles WN, Collins D, Mandalia S, Matwala K, Dutt A, Tatlock J, Singh S. Impact of inhalation injury on outcomes in critically ill burns patients: 12-year experience at a regional burns centre. Burns. 2022 Sep;48(6):1386-1395. doi: 10.1016/j.burns.2021.11.018. Epub 2021 Nov 26.

    PMID: 34924231BACKGROUND

  • Yamamura H, Morioka T, Hagawa N, Yamamoto T, Mizobata Y. Computed tomographic assessment of airflow obstruction in smoke inhalation injury: Relationship with the development of pneumonia and injury severity. Burns. 2015 Nov;41(7):1428-34. doi: 10.1016/j.burns.2015.06.008. Epub 2015 Jul 15.

    PMID: 26187056BACKGROUND

  • Kim CH, Woo H, Hyun IG, Song WJ, Kim C, Choi JH, Kim DG, Lee MG, Jung KS. Pulmonary function assessment in the early phase of patients with smoke inhalation injury from fire. J Thorac Dis. 2014 Jun;6(6):617-24. doi: 10.3978/j.issn.2072-1439.2014.04.11.

    PMID: 24976982BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

December 1, 2015

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

February 1, 2023

Record last verified: 2023-01