Microbiological evaluation of BAL fluid from patients with nosocomial Pulmonary Aspiration Syndrome compared to BAL fluid from hospitalized patients undergoing inspection bronchoscopy. A pilot study.

*Microbiological evaluation of BAL fluid from patients with nosocomial Pulmonary Aspiration Syndrome compared to BAL fluid from hospitalized patients undergoing inspection bronchoscopy. A pilot study.* - PAS pilot

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35468

Enrollment

Registered

2010-03-30

Start date

2010-03-16

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aspirationpneumonia pulmonary aspiration syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 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

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 22/minute - Treatment with antibiotics less then 48 hours prior to inclusion - history or anamnesis for aspiration in controll group patients

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
niet van toepassing	—

Countries

Netherlands

Outcome results