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Bronchoalveolar Lavage BAL for Research; Obtaining Adequate Sample Yield
Published on: March 24, 2014
Single use and conventional bronchoscopes for Broncho alveolar lavage (BAL) in research: a comparative study (NCT
Seher Raza Zaidi1,2, Andrea M Collins3,4, Elena Mitsi5
1Respiratory Infection Group, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA, UK. seher.zaidi@lstmed.ac.uk.
Insights
Single-use bronchoscopes yielded higher bronchoalveolar lavage (BAL) volumes than conventional scopes, with similar cell counts. This offers a safer, potentially more cost-effective alternative for research and early drug trials.
Area of Science:
- Pulmonology
- Medical Devices
- Clinical Research
Background:
- Bronchoalveolar lavage (BAL) is crucial for research and drug trials.
- Conventional bronchoscopes pose risks of cross-infection and incur cleaning costs.
- Single-use bronchoscopes offer a potential alternative but require evaluation.
Purpose of the Study:
- To evaluate the efficacy of single-use flexible bronchoscopes for BAL procedures in a research setting.
- To compare BAL volume yield, cell yield, and viability between single-use and conventional bronchoscopes.
- To assess the safety and cost-effectiveness of single-use bronchoscopes for research.
Main Methods:
- Healthy volunteers underwent bronchoscopy using a single-use flexible bronchoscope (Ambu® aScope™).
- BAL was performed by instilling and aspirating 200 ml normal saline.
- BAL volume, cell yield, and viability were recorded and compared to historical data from conventional scopes.
Main Results:
- Ten volunteers participated in the single-use bronchoscope group.
- Significantly higher BAL volume yield was observed with single-use scopes (median 152 ml) compared to conventional scopes (median 124 ml).
- Total cell yield and viability were comparable between both groups.
Conclusions:
- Single-use bronchoscopes provide a larger BAL volume yield than conventional scopes.
- Comparable cell yield and viability ensure research quality.
- Elimination of cross-infection risk and reduced maintenance offer safety and cost benefits for research and drug development.
Background:
Broncho alveolar lavage (BAL) is widely used for investigative research to study innate, cellular and humoral immune responses, and in early phase drug trials. Conventional (multiple use) flexible bronchoscopes have time and monetary costs associated with cleaning, and carries a small risk of cross infection. Single use bronchoscopes may provide an alternative, but have not been evaluated in this context.
Methods:
Healthy volunteers underwent bronchoscopy at a day-case clinical research unit using the Ambu® aScopeTM single-use flexible intubation bronchoscope. Broncho alveolar lavage was performed from a sub segmental bronchus within the right middle lobe; a total of 200 ml of warmed normal saline was instilled then aspirated using handheld suction. BAL volume yield, cell yield and viability were recorded.
Results:
Ten volunteers, (mean age 23 years, six male) participated. Bronchoscopies were carried out by one of two senior bronchoscopists, experienced in the technique of obtaining BAL for research purposes. The results were compared to 50 (mean age 23, 14 male) procedures performed using the conventional scope by the same two bronchoscopists. The total volume yield was significantly higher in the disposable group median 152 ml (IQR 141-166 ml) as compared to conventional 124 ml (110-135 ml), p = <0.01. The total cell yield and viability were similar in both groups, with no significant differences.
Conclusions:
With single use bronchoscopes, we achieved a larger BAL volume yield than conventional bronchoscopes, with comparable cell yield and viability. Better volume yields can potentially reduce post procedure side effects such as pleuritic chest pain and cough. The risk of cross infection can be eliminated, providing reassurance to researchers and participants. Reduced maintenance requirements can be cost effective. These could potentially be used for early phase drug development studies.
Trial Registration:
This trial was registered prospectively in July 2015 with the National Clinical Trials register, with the following registration number assigned: NCT 02515591 .
