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Healthy volunteer symptom profile following research bronchoscopy

Abstract:

Introduction: Flexible bronchoscopy (FB) with bronchoalveolar lavage (BAL) can be a valuable research tool. Soliciting of adverse events (AEs) in healthy volunteers may improve understanding of their frequency and allow refinement of pre-procedure informed consent information.

Methods: Within an ongoing study into aerosolised bacillus Calmette-Guérin (BCG), healthy adults (n=55, age 18-48 years) underwent bronchoscopy and BAL 2-8 weeks after inhaling BCG or saline placebo. Volunteers completed a daily AE diary for 7 days, with ongoing events recorded at follow-up visits.

Results: No serious adverse events were reported. There was no significant difference between those who received placebo vs aerosol BCG (χ2, p=0.753), indicating symptoms were related to the bronchoscopy rather than trial intervention. The vast majority of AEs were mild and all were self-limiting. Documented fever (>37.5oC) was recorded in 8/55 (14.5%) volunteers, all within the first 2 days post-bronchoscopy and all resolved within 48 hours. There was no association between proportion of BAL returned and fever. Those with fever had significantly more AEs overall than those without (p<0.05). Cough was the most common AE, reported in 54/55 (98%), median duration 2 days (range 1-11 days). Sore throat (52/55, 95%) and fatigue (44/55, 80%) were also commonly reported. More potentially worrisome AEs such as chest pain (14/55, 25%) and shortness of breath (16/55, 29%) were less frequent.

Conclusions: Mild AEs are common after bronchoscopy with BAL, even in healthy volunteers. Documented fever is predictive of increased number of overall AEs in the week after intervention. We did not identify any variables that predicted who would develop a fever.

Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1183/13993003.congress-2023.PA4628

Authors


More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDM
Sub department:
Jenner Institute
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDM
Sub department:
Jenner Institute
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDM
Sub department:
Jenner Institute
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
NDM
Sub department:
Jenner Institute
Role:
Author


Publisher:
European Respiratory Society
Journal:
European Respiratory Journal More from this journal
Volume:
62
Issue:
suppl 67
Article number:
pa4628
Publication date:
2023-10-27
Event title:
2023 ERS International Congress 2023
Event location:
Milan, Italy
Event website:
https://www.ersnet.org/congress-and-events/congress/
Event start date:
2023-09-09
Event end date:
2023-09-13
DOI:
EISSN:
1399-3003
ISSN:
0903-1936


Language:
English
Keywords:
Pubs id:
1599616
Local pid:
pubs:1599616
Deposit date:
2024-01-29

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