Validation of microbiological analyses of BAL (broncho alveolar lavage) fluid in patients suspected of nosocomial bacterial aspiration pneumonia.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of microbiological pathogens isolated from BAL fluid in order to
validate this technique for further research. BAL fluid obtained from patients
suspected for bacterial pulmonary infection must show growth of pathogens of at
least 103 colony forming units (CFU)/ml. Furthermore in comparison to the
controls a difference of at least 104 CFU/ml must be shown in order to identify
the organism as a pathogen. Reason for this is the fact it otherwise should be
identified as a colonist[5, 6]. After validation of microbiological findings
of BAL fluid in both groups, we will start the definite trial comparing the
outcome of BAL specimens in patients with PAS. Furthermore, we look at
biochemical markers in BAL and serum such as C-reactive protein,
pro-calcitonine and amylase.
Secondary outcome
niet van toepassing
Background summary
Pulmonary Aspiration Syndrome (PAS) can be divided in two main entities:
firstly chemical pneumonitis due to acid inoculum aspiration and secondly
bacterial aspiration pneumonia[1-3]. Less is known about the microbiological
and biochemical aspects of PAS. PAS has a high prevalence and incidence, but is
frequently under diagnosed. Also it is an important cause of serious illness
and death among hospitalized patients[4]. It will be favorable to diagnose and
distinguish both entities properly in order to give adequate treatment or
prevent overtreatment. No antibiotics are required for aspiration (chemical)
pneumonitis while specific antibiotics are needed for aspiration pneumonia. If
we are able to identify specific pathogens (e.g. anaerobic bacteria) from
patients highly suspected for bacterial aspiration pneumonia compared to
patients who have not aspirated we can start further research after pathogens
and biochemical markers in patients with PAS.
Study objective
Validation of microbiological analyses of BAL (broncho alveolar lavage) fluid
in patients suspected of nosocomial bacterial aspiration pneumonia.
Study design
Study design: Pilot study. Comparison between patients with PAS and a group of
in hospital patient*s indicated for inspection bronchoscopy.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The risk of participating this pilot study is
low. Laboratory, radiographic examinations and bronchoscopy are commonly used
as diagnostic procedures in both study groups. Performing BAL is an additional
procedure leading to temporarily increase in shortness of breath and coughing.
A decline in oxygen saturation will be treated by supplemental oxygen. In case
O2 saturation drops below 90% with supplemental oxygen the bronchoscope
procedure will be terminated. An oropharyngeal swab will be collected from each
patient. This does not have any related burden nor risk for the patient.
wilhelminalaan 12
1815 JD alkmaar
NL
wilhelminalaan 12
1815 JD alkmaar
NL
Listed location countries
Age
Inclusion criteria
• Patiënt aged 18 and older
• The presence of comorbidity with high risk for aspiration.
• Increase in respiratory symptoms such as shortness of breath, cough with or without expectoration of sputum, presence of fever for < 24 hours with fever defined as >38.5 *C.
• Elevated or increased CRP >50 mmol/l and leukocyte count > 10.0 109/l
• New consolidation X- thorax or CT-thorax after clinical suspicion of intrapulmonary infection and/or inflammation.
• Informed consent
Exclusion criteria
- Lowered conciousness: desoriented in time, place, person.
- Obstruction pneumonia (e.g. from lung cancer).
- Severe immunosuppression (HIV infection, chemotherapy).
- Suspicion of TBC.
- Mechanical ventilation <72 h prior to inclusion
- Respiratory insufficiency defined as peripheral O2 saturation under 90% without supplemental oxygen and/or breathing frequency > 22/minute
- Treatment with antibiotics less then 48 hours prior to inclusion
- history or anamnesis for aspiration in controll group patients
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 | NL28237.094.09 |