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 (?2, 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.