RESUMEN
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. Our Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and MEB. The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation as a group, rather than for each individual patient. Data were collected prospectively on 1,244 group patient-treatment exposures, collectively including 5,072 individual patient-treatment/exposures. We randomly assigned patient-treatment group exposures to four different time interval and rate (slope) of compression. These compression rates and slopes were identical to those used in the Phase I trial. All patients experiencing symptoms of MEB requiring compression stops were evaluated post treatment for the presence of ETD and MEB using the O'Neill Grading System (OGS) for ETD. Data were analyzed using the IBM-SPSS statistical software program. A statistically significant decrease in the number of compression holds was observed in the 15-minute compression schedule, correlating to the results observed in the Phase I trial. The 15-minute linear compression profile continues to demonstrate the decreased need for patient symptomatic compression stops (as in the Phase I trial) using a USN TT9 during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber. Trial Registration: ClinicalTrials.gov Identifier: NCT04776967.