Measures for Bioaerosol Reduction in the Salmon Industry

NCT05039229 | Enrolling By Invitation

• 1 other identifier: 131052/13118
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Workers in the salmon industry are at risk of developing allergies and respiratory diseases, including asthma, due to occupational exposure to bioaerosols, i.e. biological agents such as allergens, enzymes and endotoxins, in their work environment. The overall objective of this intervention trial is to identify effective and feasible control measures (interventions) that reduce exposure to these bioaerosols. The project comprises nine salmon processing factories in northern, central and western Norway. The factories are allocated to either one of the two intervention arms or the control group. In all factories, an assessment of exposure to bioaerosols will be performed. In addition, employees will be invited to undergo a health examination and fill out a self-administered questionnaire including information on demographics, work tasks, health and health promoting factors. The intervention trial is part of a broader study that comprises several substudies including the identification of clinically relevant allergens, investigation of exposure-response relationship between the exposure to individual bioactive agents in bioaerosols and investigations of prevalence of airway symptoms, altered lung function, skin symptoms or immunological responses indicating hypersensitivity. Finally the project includes the identification of health promoting factors that are present in the salmon processing industry. The project is an interdisciplinary multi-center study that places great emphasis on a close dialogue between the researchers and industry in all phases of the project.

Conditions

Asthma, Occupational; Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Change of salmon processing workers' personal exposure to inhalable protein

  Change in inhalable total protein (ug/m3) in the workers' breathing zone from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences in mean concentration of full shift measurements (8 hours) between intervention groups and between intervention groups and control group will be analyzed.

  Measurements at T1 compared to T2, 12 months after T1.

Secondary Outcomes (13)

• Change of salmon processing workers' personal exposure to proteases

  Measurements at T1 compared to T2, 12 months after T1.

• Change in area concentration of airborne total protein (stationary measurements)

  Measurements at T1 compared to T2, 12 months after T1.

• Change of salmon processing workers' personal exposure to airborne fish allergens

  Measurements at T1 compared to T2, 12 months after T1.

• Change of salmon processing workers' personal exposure to airborne endotoxins

  Measurements at T1 compared to T2, 12 months after T1.

• Change in salmon processing workers' self-reported symptoms from the upper airways

  Data collected at T1 compared to T2, 12 months after T1.

Study Arms (3)

Nozzles (NZ)

EXPERIMENTAL

Intervention with the aim of reducing bioaerosol exposure for the employees, targeting alteration of nozzles or nozzle function along the production line.

Other: Nozzles (NZ)

Cleaning of surfaces (CS)

EXPERIMENTAL

Intervention with the aim of reducing bioaerosol exposure for the employees while cleaning their personal operating areas (work benches and part of production lines) during work operations or while cleaning floor areas.

Other: Cleaning of surfaces (CS)

Control (CTR)

NO INTERVENTION

Work is to be carried out as usual without any intervention measures. Follow-up according to the same schedule as for the other intervention groups.

Interventions

Nozzles (NZ) OTHER

Technical intervention targeting alteration of nozzles or nozzle function along the production line, e.g. by manipulation of nozzle dimensions, alteration of operating pressure or shielding of the nozzle's output stream. How the intervention is to be carried out in detail in the respective factory is to be developed in collaboration with the factory staff. This can include local specific characteristics, specific location of intervention or others.

Nozzles (NZ)

Cleaning of surfaces (CS) OTHER

Behavioural or technical intervention. This can include increased use of swabbing instead of flushing with water hoses or alterations in use of water hoses for cleaning. Examples for the latter are a reduced flushing frequency, reduction of number of employees executing the work, alterations of hose dimension or nozzles on hoses. How the intervention is to be carried out in detail in the respective factory is to be developed in collaboration with the factory staff. This can include local specific characteristics, specific location of intervention or others.

Cleaning of surfaces (CS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Exposure assessment study
• Monday and Thursday (n=12 workers): Slaughtering department (n=5), filleting department (n=4) and other (n=3).
• Tuesday and Wednesday (n=12 workers): Slaughtering department (n=3), filleting department (n=3), packing department (n=2), laboratory/technical department (n=2) and central control room/administration (n=2).
• For spirometry measurements: heart attack, operation on eyes, stomach or in the chest region in the course of the last three months, ongoing treatment for tuberculosis or other respiratory infection, pregnancy
• For skin prick tests: pregnancy

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Research Council of Norway: collaborator
• UiT The Arctic University of Norway: collaborator
• St. Olavs Hospital: collaborator
• Haukeland University Hospital: collaborator
• University of Bergen: collaborator

Study Sites (1)

University Hospital of Nothern Norway

Tromsø, Norway

Location

Related Publications (1)

• Hoper AC, Kirkeleit J, Thomassen MR, Irgens-Hansen K, Hollund BE, Fagernaes CF, Svedahl SR, Eriksen TE, Grgic M, Bang BE. Effects of Interventions to Prevent Work-Related Asthma, Allergy, and Other Hypersensitivity Reactions in Norwegian Salmon Industry Workers (SHInE): Protocol for a Pragmatic Allocated Intervention Trial and Related Substudies. JMIR Res Protoc. 2023 Jul 19;12:e48790. doi: 10.2196/48790.

  PMID: 37467018 BACKGROUND

MeSH Terms

Conditions

Asthma, Occupational; Hypersensitivity

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Occupational Diseases

Study Officials

• Berit E Bang, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 9, 2021
• Study Start: September 20, 2021
• Primary Completion: June 30, 2023
• Study Completion: April 30, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

NO (1)