Incidence of serious adverse events during nocturnal polysomnography.
OBJECTIVE
The purpose of the study was to verify whether minimal concern is warranted in regard to serious adverse effects in the sleep laboratory.


METHODS
A prospective multicenter study


METHODS
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.
Mehra
Reena
R
Center for Sleep Disorders Research, Louis Stokes DVA Medical Center, Case Western Reserve University Cleveland, OH, USA. mehrar@ameritech.net
Strohl
Kingman P
KP
D000328:Adult; D016010:Binomial Distribution; D002423:Cause of Death; D045422:Continuous Positive Airway Pressure; D003430:Cross-Sectional Studies; D004630:Emergencies / Q000453:epidemiology*; D019544:Equipment Failure Analysis; D005260:Female; D006323:Heart Arrest / Q000401:mortality; D006801:Humans; D008297:Male; D008432:Mathematical Computing; D008875:Middle Aged; D010343:Patient Admission; D017286:Polysomnography / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D011446:Prospective Studies; D011785:Quality Assurance, Health Care; D012307:Risk Factors; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000401:mortality; D012893:Sleep Wake Disorders / Q000175:diagnosis* / Q000401:mortality; D017180:Tachycardia, Ventricular / Q000401:mortality; D014481:United States / Q000453:epidemiology