Trial document





This trial has been registered retrospectively.
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  DRKS00003210

Trial Description

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Title

Effectiveness of personal protective equipment (Disposable Respirators - German classification: FFP2) to protect respiratory health of employees in poultry farming

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Agricultural workers often suffer from chronic respiratory diseases. This holds true especially for animal husbandry, e.g. poultry farming. With regard to occupational health, employees are advised to use disposable respiratory masks (class FFP 2) though lack of evidence for this protective measure. Against this background, the effectiveness of using respiratory masks is investigated by assessing airways reaction pattern in a randomized-controlled interventional study.
Study participants of the intervention group receive an education on respiratory health in agriculture and protective measures with special emphasis on the use of disposable respiratory masks. In addition, they are provided with an amount of disposable protective respiratory masks (FFP2) sufficient for the intervention period (3 months). Controls are educated at the end of the study period. Before and after the intervention period, substances and cells marking inflammation are examined in the nasal washing fluid, lung function test are performed (spirometry), possible sensitisation against respiratory allergens is tested (serum), and complaints are assessed by questionnaire.
The results of the study will encourage scientific discussion on the effects of airborne biological hazards in agriculture and the appropriate personal protective equipment for agricultural workers.

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Brief Summary in Scientific Language

Agricultural workers often suffer from chronic respiratory diseases. This holds true especially for animal husbandry, e.g. poultry farming, where the high exposure to bioaersols seems to be a major risk factor. With regard to occupational health, employees are advised to use disposable respiratory masks (class FFP 2) though lack of evidence for this protective measure. In addition, in many agricultural fields, the concentration of e.g. airborne endotoxins is discussed to be too high for sufficient protection by respiratory masks. Against this background, the effectiveness of the advice to use disposable respiratory masks is investigated by a cluster-randomised-controlled interventional trial.
The complex intervention consists of an education on respiratory health in agriculture and protective measures with special emphasis on the use of disposable respiratory masks as well as of the provision of an amount of disposable protective respiratory masks (FFP2) sufficient for the intervention period (3 months). Controls are educated at the end of the study period and receive no further intervention. Before and after the intervention period, cytokines and leukocytes in the nasal washing fluid are examined (primary outcomes: IL-8, TNF-α), lung function test are performed (spirometry), possible sensitisation against respiratory allergens is tested (serum), and complaints are assessed by questionnaire. Statistical analysis is performed by descriptive analysis and analysis of variance (ANOVA) by SPSS©.
The results of the study will encourage scientific discussion on the effects of airborne biological hazards in agriculture and the appropriate personal protective equipment for agricultural workers.

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Organizational Data

  •   DRKS00003210
  •   2011/09/12
  •   [---]*
  •   yes
  •   Approved
  •   90/2008, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J40-J47 -  Chronic lower respiratory diseases
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Intervention group: After having an initial motivational education on preventing airways diseases in agriculture and how to wear disposable respirators correctly, participants are provided with a sufficient number of respirators for three month.
  •   Participants of this group perform work in poultry farming as usual, i.e. without specific motivation for protection measures. They are going to receive education on the prevention of respiratory diseases in their occupational area at the end of the study period.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Prevention
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

At the beginning and after three month (+/- two weeks): Cytokines in nasal lavage fluid (NALF):
IL-8 and TNF-a

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Secondary Outcome

At the beginning and after three month (+/- two weeks):- More cytokines (IL-1ß, IL-5, LTB4, sCD14, NO) and leukocytes in NALF; - Parameters of lung function: FVC%, FEV1%, FEV1%FVC%; - Questionnaire items: complaints, quality of life, comfort when using respiratory masks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/01/06
  •   112
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Employees in poultry farming working inside stables for more than 30 min per day.

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Exclusion Criteria

1. Existence of an ariways disease, that does not allow using disposable respiratory masks
2. Having a full beard
3. Lack of German language knowledge
4. Expected end of occupation before the end of study period

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Arbeits- und Sozialmedizin Universitätsklinikum Tübingen
    • Ms.  Prof. Dr.med.   Monika A.  Rieger 
    • Wilhelmstr. 27
    • 72074  Tübingen
    • Germany
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    • Institut für Arbeits- und Sozialmedizin Universitätsklinikum Tübingen
    • Ms.  Nicole  Blomberg 
    • Wilhelmstr. 27
    • 72074  Tübingen
    • Germany
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    • Institut für Arbeits- und Sozialmedizin Universitätsklinikum Tübingen
    • Ms.  Nicole  Blomberg 
    • Wilhelmstr. 27
    • 72074  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministeriums für Landwirtschaft und Verbraucherschutz (BMELV) durch die Bundesanstalt für Landwirtschaft und Ernährung
    • Deichmanns Aue 29
    • 53179  Bonn
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/05/14
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Trial Publications, Results and other Documents

  •   Blomberg N, Nübling M, Raulf-Heimsoth M, Rieger MA. Untersuchung zur Effektivität von partikelfiltrierenden Halbmasken (FFP2) bei Beschäftigten in Geflügelhaltungsbetrieben. 50. Jahrestagung, Deutsche Gesellschaft für Arbeitsmedizin und Umweltmedizin e.V., 16. bis 19. Juni 2010 Dortmund. Arbeitsmedizin Sozialmedizin Umweltmedizin 2010; 45(6): 299-300.
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* This entry means the parameter is not applicable or has not been set.