Incidence of serious adverse events during nocturnal polysomnography

Abstract

Objectives: The purpose of the study was to verify whether minimal concern is warranted in regard to serious adverse effects in the sleep laboratory. Design: A prospective multicenter study Participants: Three scoring teams for 17 sleep laboratories. Methods: Reports of adverse events occurring during polysomnography or identified upon scoring a study were collected over an 18-month time period. Incidence of mortality and adverse events were evaluated using a binomial distribution based on the Bernoulli process. Results: Of 16,084 studies, the mortality rate during or 2 weeks after an adverse event, as noted, was 0.006%, and the overall rate of adverse events was 0.35%. Conclusions: Adverse event rates are low; however, procedures for handling medical emergencies or adverse events during or after polysomnography are prudent, and those studies performed for research should include preparedness for the possibility of adverse events.