The SHIELD Whole Lung Lavage Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-12-31

Brief Summary

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An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.

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Detailed Description

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BACKGROUND: Silicosis is a fatal lung disease caused by inhaling silica particles. Australia is currently facing an epidemic with hundreds of young workers having contracted silicosis from machining engineered stone.

AIMS: To determine the effectiveness and safety of Whole Lung Lavage (WLL) in workers with silicosis due to significant engineered stone exposure.

DESIGN: Participants (30) with silicosis or silica-induced bronchitis who are scheduled to undergo WLL as part of their normal care will be enrolled. They will undergo the following interventions pre and 3 months post WLL, some of which would have been carried out as part of routine standard care:

1. Complex pulmonary function tests (PFTs) - standard care
2. HRCT scan (if not within 6 months of WLL) - standard care
3. Blood tests
4. Cardiopulmonary exercise testing
5. Forced oscillatory technique
6. XV Lung Ventilation Analysis
7. Questionnaires (K-BILD and LCQ)

Conditions

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Silicosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Whole Lung Lavage

Whole Lung Lavage (WLL) is performed as standard of care. Outcome following WLL is observed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Males and females aged \>=18 years and scheduled for WLL at the study site as part of routine clinical care
* History of exposure to respirable crystalline silica (RCS) while working in an at-risk industry (e.g. stonemasonry, construction, tunnelling, concreting, mining)
* Elimination of workplace exposure to RCS for a minimum of 6 months
* Ground glass nodularity \> extent of solid nodularity on HRCT, as judged by investigator or evidence of silica-induced bronchitis
* Evidence of disease progression within the past 2 years, defined as any of

* a relative decline in the FVC or FEV1 of at least 5% of the predicted value,
* worsening of respiratory symptoms
* increased extent of silicosis on high-resolution CT scan
* Able to understand and sign a written informed consent form (or legally authorised representative)

Exclusion Criteria

* Ongoing workplace exposure to RCS or removal of workplace exposure of less than 6 months
* Progressive massive fibrosis, defined as areas of confluent fibrosis with diameter \> 10mm on HRCT.
* FEV1 or FVC \< 50% predicted
* DLCO \<50% predicted
* Contraindication to WLL, as judged by the investigator
* Actively or imminently listed for lung transplantation
* Females with a positive pregnancy test at screening or currently breastfeeding
* Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 24 months
* Any condition other than silicosis that, in the opinion of the investigator, is likely to result in the death of the participant within the next 24 months
* Significantly impaired cardiac function

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No