Introduction: Hyperbaric oxygen (HBO2) therapy is applied in a growing number of cases for patients with different comorbidities and is considered a generally safe therapy. The main side effects related to HBO2 therapy are barotrauma, central nervous system- and pulmonary oxygen toxicity, claustrophobia, anxiety and visual disturbances. The aim of this study was to evaluate the incidence of side effects associated with HBO2 therapy and risk factors in a large cohort of patients treated for different indications.

Methods: We conducted a retrospective analysis of 2,334 patients treated in the Sagol Center of Hyperbaric Medicine and Research, Assaf Harofeh, Israel, between June 2010 and December 2014. Patients were classified to one of three categories of indications: Category A--non-neurological indications; Category B--neurotherapeutic indications; and Category C--acute indications.

Results: From a total of 2,334 patients, 406 (17.4%) experienced adverse event(s) (one or more) during HBO2 therapy sessions. The overall per-session incidence was 721:100,000 events:sessions (0.72%). The main complication was middle ear barotrauma, which occurred in 9.2% of patients and in 0.04% of sessions. Females and children under the age of 16 years had increased risk for barotrauma. Other complications--hypoglycemia, oxygen toxicity, dizziness, anxiety reactions, dyspnea and chest pain--occurred in 0.5-1.5% of patients.

Conclusions: Strict operational protocols, including pre-HBO2 therapy evaluations and in-chamber monitoring, are essential and improve patient safety. When applied, HBO2 therapy can be considered one of the safest medical treatments available today.

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