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Inhalation InjuryNCT05705713

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

A study testing chest computed tomography (CT) in people with Inhalation Injury, run by Menoufia University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inhalation Injury
What is being tested?
chest computed tomography (CT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
No sites listed yet
Study dates
1 Dec 2015to 1 Mar 2019
Phase
Interventional
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

Who may be able to join

  • any patient with a suspected inhalational lung injury

Who cannot join

  • 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.

About this study

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.

Read the 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).

Being tested
chest computed tomography (CT)
Keywords
inhalation injury, Bronchial wall thickening, Radiologist score, computed tomography.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05705713
Study groupRoleWhat they receive
CasesExperimental48 participants with burn injuries associated with inhalation lung injuries were recruited from the burn department.
Receives: Radiation: chest computed tomography (CT)
ControlActive comparator10 participants with burn injuries NOT associated with inhalation lung injuries were recruited from the burn department.
Receives: Radiation: chest computed tomography (CT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bronchial wall thickening (BWT)

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

    Measured: 24 hours

  2. 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.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2023
  2. Study start1 Dec 2015
  3. Primary completion1 Jan 2019
  4. Study completion1 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05705713
Sponsor's protocol ID
12/2022COM2
Status last verified
Jan 2023
First submitted
20 Jan 2023
Last updated
1 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 17969244

  • 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.

    PubMed 29461292

  • 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.

    PubMed 3366733

  • 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.

    PubMed 22067627

  • 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.

    PubMed 20006445

  • 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.

    PubMed 22210063

  • 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.

    PubMed 26507130

  • 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.

    PubMed 23706091

  • 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.

    PubMed 34924231

  • 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.

    PubMed 26187056

  • 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.

    PubMed 24976982

Questions about this trial

What is this clinical trial studying?

A study testing chest computed tomography (CT) in people with Inhalation Injury, run by Menoufia University.

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 1 inclusion and 4 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 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

bronchial wall thickening (BWT) (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT05705713, which also lists 11 linked publications.

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 1 Feb 2023.

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