RASECAL-Bronchoscopic ambusampler RCT - safety and efficiency
A Randomized controlled trial to Assess the Safety and Efficiency of a self-Contained sampling device /disposable bronchoscope system versus usual sAmpLing procedure. RASECAL
Chelsea and Westminster Hospital
Duration of Study in the UK
1 years, 0 months, 0 days
Bronchoscopy is designated an aerosol generating procedure (AGP). Hence the potential risks of staff contamination. As such its use in mechanically ventilated patients with COVID-19 has been recommended only following a careful risk-benefit assessment. And yet, bronchoscopy in the intensive care has important diagnostic and therapeutic roles. These include diagnosis of infection through directed sampling, and therapeutic lavage to resolve partial lung collapse due to airway secretions. Single use only bronchoscopes form part of safe-practice advice. Additional measures to minimize aerosolisation are suggested. Bronchoscopic sampling of bronchoalveolar fluid must then be performed safely and effectively. Current practice of sampling containers connected to and resting loosely between the bronchoscope and wall suction, risks loss of sample to the waste container. Moreover, the need to replace full sampling containers during the procedure is subject to aerosolisation, spillage or contamination of the collected sample.
The novel integrated AmbuBronchosampler is designed to allow bronchial lavage with minimal aerosol leak during the procedure. The 30ml container is attached to its single use Ascope 4 bronchoscope through a bridge adaptor with an external dial that controls the flow of bronchial fluid into the collection container or to the wall suction by simple thumb movement. This enables an upright sampling container throughout the procedure-so minimizing sample loss, and allows change of containers intraprocedurally without risking aerosolisation. The AmbuBronchosampler has been shown to be more efficient (i.e. easier set up and workflow) with good specimen yield, and potentially safer (i.e. fewer inadvertent disconnections, or fluid spillage) compared against standard bronchoscopic sampling practice in a 20 procedure case series by a single operator; albeit with risk of observer bias. This randomized control trial, will assess whether the new Ambusampler is safer, more effective and reliable than standard bronchoscopic sampling techniques. This will be important for future procedures on ICU.
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
Date of REC Opinion
15 Jun 2021
Further Information Favourable Opinion