Safety of Hyperbaric Oxygenation Treatment and Evaluation of Associated Clinical Parameters: A Single-Institutional Prospective Cohort Study

Abstract

Background and Objective: Adverse events (AEs) associated with hyperbaric oxygen therapy (HBOT) are uncommon and typically not serious, being the most frequent otic/sinus barotrauma. The objective of this study is to analyze the safety of the HBOT at 1.45 atmosphere absolute (ATA) and compare it with reportsat the same and higher pressures of treatment. AE per session was 7.1% for total AE and 4.1% for overall barotrauma. AE was reported in 28.3% of patients (n=49), with barotrauma and non-barotrauma AE in 20.3% (n=35) and 8.1% (n=14). All barotrauma was recorded as subjective (100% of ear ache without eardrum damage, Teed scale=0). The frequency of total AE obtained in our study was statistically higher for 1.5, 2, and >2 ATA. Non-barotrauma AE was also higher; the frequency of total AE obtained in our study was statistically significant for 1.5, 2, and >2 ATA but objective barotrauma was not present, and it was significantly lower than previously reported (p < 0.001). A very slow rate of pressurizations (below 1 psi/min) was associated with ear pain (OR=3.32; 95 CI%, 1.32-8.35; p < 0.001). The AEs reported in this safety surveillance prospective study are minor, and no objective barotrauma was reported. HBOT at 1.45 ATA is a safe treatment, that can be performed with a portable light and a less expensive hyperbaric chamber. Methods: A total of 175 patients (68 male, 107 female) were included in this prospective study. All patients were treated with HBOT at our facility from December 2019 to August 2021. For the comparative analysis, reports from studies published from 2012 to 2021 in MEDLINE EMBASE, BIREME, Lilacs, Scielo, and the Cochrane library were used. Binary variables are described in percentages with a 95% confidence interval (95% CI). Inferential analysis was performed using a bivariate analysis by calculating odds ratio (OR) with 95% confidence intervals. Statistical analyses and sample size calculations were performed with Stata version 13.0 (College Station, TX, USA). Results: In this study, the AE per session was 7.1% for total AE and 4.1% for overall barotrauma. AE was reported in 28.3% of patients (n=49), with barotrauma and non-barotrauma AE in 20.3% (n=35) and 8.1% (n=14), respectively. All barotrauma was recorded as subjective (100% of ear ache without eardrum damage, Teed scale=0). The frequency of total AE obtained in our study was statistically higher for 1.5, 2, and >2 ATA. Non-barotrauma AE was also higher, but objective barotrauma was not present and was significantly lower than previously reported (p <0.001). A very slow rate of pressurizations (below 1psi/minute) was associated with ear pain (OR = 3.32; 95% CI, 1.32-8.35; p <0.001). Conclusion and Implications for Translation: In this study, the AE reported in this prospective safety surveillance study are minor, and no objective barotrauma was reported. The HBOT at 1.45 ATA is a safe treatment that can be performed with a portable lighter and a less expensive hyperbaric chamber. This study supports the hypothesis that hyperbaric oxygenation therapy at 1.45 ATA is a safe treatment, allowing for the spread and application of adjuvant treatment in different pathologies. Copyright © 2023 Monge-Martínez, et al. Published by Global Health and Education Projects, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution License CC BY 4.0.