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First-day Computed Tomography: Does it Has a Role in the Assessment of Patients With Inhalation Lung Injury?

Primary Purpose

Inhalation Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
chest computed tomography (CT)
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inhalation Injury focused on measuring inhalation injury, Bronchial wall thickening, Radiologist score, computed tomography.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: any patient with a suspected inhalational lung injury Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cases

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    bronchial wall thickening (BWT)
    measured through a CT chest scan at the end inspiration 2 cm distal to the tracheal bifurcation.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2023
    Last Updated
    January 30, 2023
    Sponsor
    Menoufia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05705713
    Brief Title
    First-day Computed Tomography: Does it Has a Role in the Assessment of Patients With Inhalation Lung Injury?
    Official Title
    First-day Computed Tomography: Does it Has a Role in the Assessment of Patients With Inhalation Lung Injury?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2019 (Actual)
    Study Completion Date
    March 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menoufia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Forty-eight patients with inhalation lung injury were included in the study as the case group, and ten patients without ILI were chosen as the control group. Both groups were recruited from the burn and plastic department. A fiberoptic bronchoscope was performed during the first 12 hours of a suspected ILI to confirm the diagnosis. After performing an initial chest X-ray, computed tomography was used to calculate the radiologist score (RADS) and the thickness of the bronchial walls (BWT).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inhalation Injury
    Keywords
    inhalation injury, Bronchial wall thickening, Radiologist score, computed tomography.

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cases
    Arm Type
    Experimental
    Arm Description
    48 participants with burn injuries associated with inhalation lung injuries were recruited from the burn department.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    10 participants with burn injuries NOT associated with inhalation lung injuries were recruited from the burn department.
    Intervention Type
    Radiation
    Intervention Name(s)
    chest computed tomography (CT)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    bronchial wall thickening (BWT)
    Description
    measured through a CT chest scan at the end inspiration 2 cm distal to the tracheal bifurcation.
    Time Frame
    24 hours
    Title
    Radiologist score
    Description
    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.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: any patient with a suspected inhalational lung injury Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17969244
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29461292
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3366733
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22067627
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20006445
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22210063
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26507130
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23706091
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34924231
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26187056
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24976982
    Citation
    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.
    Results Reference
    background

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    First-day Computed Tomography: Does it Has a Role in the Assessment of Patients With Inhalation Lung Injury?

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