A randomized controlled trial to assess the safety and efficiency of a self-contained sampling device /disposable bronchoscope system versus usual sampling procedure (rasecal)
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Author(s)
Type
Journal Article
Abstract
Background:
Bronchial washing can be inefficient or unsafe, through aerosolization, poor yield and loss of sample. Set-up and connectivity of sampling containers is often challenging. Further, process of bronchoscopy in ICU is inadequately reported.
We tested if a novel closed bronchoscopy sampling system is safer, and more efficient than standard sampling technique. And recorded variation of bronchoscopy practice in mechanically ventilated patients.
Methods:
A multicentre RCT saw 188 bronchoscopies performed in mechanically ventilated patients requiring diagnostic sampling. Closed system Ambu bronchosampler TM, ABS was compared to standard sampling containers (SSC) with single use bronchoscopes (Ambu A4TM) for primary outcomes of safety (spill, unplanned disconnection) and efficiency (ease of connectivity, setup, loss of sample, % volume retrieved), secondary efficiency outcomes and tertiary of bronchoscopy process.
Results:
ABS was safer than SSC; spills 0% v 23.7% [0/94 v 22/93], p<0.001; Unplanned tube disconnections 5.3% v 21.3%, [5/95 v 20/93], p<0.001; Unplanned container disconnections 2.1% v 7.5% [2/95 v 7/93], p=0.08. Efficiency was significantly higher in ABS than SSC (acceptable/(very)easy) Set up 98.9% v 82.8% [94/95 v 77/93], Connectivity 100% v 54.7% [88/88 v 47/86], Upright 98.9% v 10.8% [94/95 v 10/93], Sample loss 11.6% v 48.4% [11/95 v 45/93], all p<0.001. Volume retrieved% unchanged (33.0% v 35.4%, p>0.2).
Bronchoscopy for infection in 80.9%, therapeutic lavage in 51% and infrequently otherwise. Prior imaging in 93.2%, preprocedural checklists/timeouts in 83.5% and post procedure CXRs in 78.2%.
Mandatory ventilation was most common peri-bronchoscopy. Neuromuscular blockade in 73.8% and recruitment manoeuvres in 34.7%. The bronchoscope was not removed intraprocedurally in 80.2%, of cases. Positive microbiology in 45.7% samples. Adverse events were rare <5%.
Conclusions :
Closed system bronchoscopic sampling was safer (less spill, unplanned disconnections) and more efficient(set up, connectivity, loss prevention) than standard containers. Closed system diagnostic sampling devices should be the standard during bronchoscopy.
Bronchial washing can be inefficient or unsafe, through aerosolization, poor yield and loss of sample. Set-up and connectivity of sampling containers is often challenging. Further, process of bronchoscopy in ICU is inadequately reported.
We tested if a novel closed bronchoscopy sampling system is safer, and more efficient than standard sampling technique. And recorded variation of bronchoscopy practice in mechanically ventilated patients.
Methods:
A multicentre RCT saw 188 bronchoscopies performed in mechanically ventilated patients requiring diagnostic sampling. Closed system Ambu bronchosampler TM, ABS was compared to standard sampling containers (SSC) with single use bronchoscopes (Ambu A4TM) for primary outcomes of safety (spill, unplanned disconnection) and efficiency (ease of connectivity, setup, loss of sample, % volume retrieved), secondary efficiency outcomes and tertiary of bronchoscopy process.
Results:
ABS was safer than SSC; spills 0% v 23.7% [0/94 v 22/93], p<0.001; Unplanned tube disconnections 5.3% v 21.3%, [5/95 v 20/93], p<0.001; Unplanned container disconnections 2.1% v 7.5% [2/95 v 7/93], p=0.08. Efficiency was significantly higher in ABS than SSC (acceptable/(very)easy) Set up 98.9% v 82.8% [94/95 v 77/93], Connectivity 100% v 54.7% [88/88 v 47/86], Upright 98.9% v 10.8% [94/95 v 10/93], Sample loss 11.6% v 48.4% [11/95 v 45/93], all p<0.001. Volume retrieved% unchanged (33.0% v 35.4%, p>0.2).
Bronchoscopy for infection in 80.9%, therapeutic lavage in 51% and infrequently otherwise. Prior imaging in 93.2%, preprocedural checklists/timeouts in 83.5% and post procedure CXRs in 78.2%.
Mandatory ventilation was most common peri-bronchoscopy. Neuromuscular blockade in 73.8% and recruitment manoeuvres in 34.7%. The bronchoscope was not removed intraprocedurally in 80.2%, of cases. Positive microbiology in 45.7% samples. Adverse events were rare <5%.
Conclusions :
Closed system bronchoscopic sampling was safer (less spill, unplanned disconnections) and more efficient(set up, connectivity, loss prevention) than standard containers. Closed system diagnostic sampling devices should be the standard during bronchoscopy.
Date Acceptance
2026-08-08
Citation
BMJ Open Respiratory Research
ISSN
2052-4439
Publisher
BMJ Publishing Group
Journal / Book Title
BMJ Open Respiratory Research
Copyright Statement
Copyright This paper is embargoed until publication. Once published the Version of Record (VoR) will be available on immediate open access.
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Publication Status
Accepted