Primary Objective: To perform BAL in healthy volunteers, who can serve as control subjects in (future) studies.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Relative frequencies of different monocyte and lymphocyte subtypes.
Protein analyses
Secondary outcome
not applicable
Background summary
Bronchoalveolar Lavage (BAL is part of the standard diagnostic procedure for
patients suspected of interstitial lung diseases (ILDs).1
Fluid obtained by lavage can be analyzed cytologically (cellular component) and
chemically (non cellular component). Analyses of the cellular component include
the relative quantity of different cell types (lymphocytes, neutrophils,
eosinophils) and cell-subtypes. In addition to the cellular component, proteins
present in the fluid and in cells themselves can be analyzed by mass
spectrometry.
Regarding Interstitial Lung Diseases, the most prominent value of BAL is its
role in the diagnostic procedure, for in some conditions levels of a specific
cell-(sub)type or protein can be either elevated or reduced. This knowledge is
not only useful for diagnostic purposes, as elevation or reduction of a
specific cell-type or protein can also provide information about the underlying
pathologic processes. Furthermore, BAL can also be used in the assessment of
disease severity, and in extension, for evaluation of treatment.
In the St. Antonius Hospital, many patients with an ILD are treated and
scientific research on the etiology of these diseases is conducted, some in
which results of BAL are used. To facilitate these studies, we are planning to
conduct a series of Bronchoalveolar Lavages in healthy volunteers. The results
of the current study will be used as *control* values in the different studies
involving BAL that are and will be conducted at the department of pulmonary
diseases. These are predominantly studies trying to dissolve the etiology of
sarcoidosis and other ILDs.
Study objective
Primary Objective: To perform BAL in healthy volunteers, who can serve as
control subjects in (future) studies.
Study design
This study is of an observational design, and involves invasive measurements.
Bronchoalveolar Lavage and venipuncture are once performed in healthy
volunteers.
Study burden and risks
Single venipuncture for atopy screening, if negative then continuation with
study:
Single roentgenologic examination of the thorax and simple spirometry (to
exclude pulmonary diseases)
Single Bronchoalveolar Lavage and venipuncture (100 ml). Risks and side effects
during lavage: Dyspnea. Side effects after Lavage: Pharyngeal Irritation,
coughing, fever, pain when breathing. The risks of drawing blood from a vein
are minimal.
Postbus 25
3430 EM
Nederland
Postbus 25
3430 EM
Nederland
Listed location countries
Age
Inclusion criteria
-age between 18 and 65 years
-capability of giving informed consent
Exclusion criteria
- pulmonary disease
- diseases related to the immune system
- active infection
- immunosuppressive medication
- employees of the departments of pulmonary medicine and Medical Microbiology and Immunology are excluded from participation
- exclusion criteria for undergoing bronchoalveolar lavage
- if atopy screening is positive i.e. IgE > 100 and/or phadia-top >1
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL12191.100.06 |