Barotrauma otic3/29/2023 ![]() Unit of observations as a multiplace patient-treatment group exposure rather than individual Trial collected from Septemto September 8, 2016. This was similar to the Phase I study.ĭata will be collected prospectively on all patients recruited and receiving treatment fromįebruary 11, 2019, and February 10, 2020, and combined with the data obtained in our Phase I (slope) and time intervals of compression. Will prospectively collect data on patient-treatment group exposures after formalizing fourĭifferent compression schedules each including a unique combination of compression rate Treatment and will be used as a baseline compression rate to compare all other compression (slope) of compression rate was maintained throughout the total 10-minute time interval of Representing a 4.5 fsw/minute uniform rate of compression. The chamber was compressed over a 10-minute time interval Multiplace chamber treatment protocol to a depth of 45 feet of seawater (fsw) (modified U.S. All patients experiencing symptoms of MEB requiring compression stops will beĮvaluated post-treatment for the presence of ETD and MEB using the O'Neill Grading Systemįor approximately 10 years, the investigators hyperbaric center used a routine daily These compression rates and slopes were identical to those used in the Received all 4 compression profiles (CP) on a rotating basis, in effect having patients serveĪs their own controls in a crossover design and to reduce the risk of treatment order on theĮffects observed. All patients, within every patient-treatment group exposure, Will randomly assign patient-treatment group exposures to four different time interval and This Phase II study investigates an optimal rate of compression to reduce ETD and MEB whenĬonsidering each multiplace treatment (with multiple patients) as the unit of observation asĪ group, rather than for each individual patient. ![]() Interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. The Phase I Trial suggested the total time Symptomatic ETD and middle ear barotrauma (MEB). The first to demonstrate a statistically significant decrease in the occurrence of Procedure: Hyperbaric Compression ProfileĬomplications during hyperbaric oxygen treatment.This will increase power to facilitate detailedĭescriptive analysis and to determine if the findings are robust in the phase I study. The sample size of treatments and they will be combined with the total number of treatments Patients requiring first stops in the 4 compression profiles. Analysis using descriptive and inferential statistics will be applied to the Stops (as in the Phase I trial) using a United States Navy Treatment Table 9 (USN-TTN9)ĭuring elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber willīe analyzed. Patients who are symptomatic and require compression The number of compression holds observed in each of the 4 compression schedules, similar to Data will beĪnalyzed using the IBM-SPSS statistical software program. Symptoms of ETD and MEB requiring compression stops will be evaluated post treatment toĬonfirm the presence of ETD and MEB using the O'Neill Grading System (OGS). ![]() These total time intervals of compression and rates (slopes) ofĬompression are identical to those used in the Phase I trial. Randomly assigned patient-treatment group exposures to four different time interval and rate Observation collectively as a group, rather than for each individual patient.ĭata will be collected prospectively on group patient-treatment exposures. When considering each multiplace treatment (with multiple patients) as the unit of Investigates an optimal total time interval and rate of compression to reduce ETD and MEB (slope) of compression (ROC) may be a determining factor in ETD and MEB. The Phase I Trial suggested the total time interval and rate The Phase I study data was the first toĭemonstrate a statistically significant decrease in the occurrence of symptomatic ETD and Patients Per Site Per Month Study Details Study Description Brief SummaryĮustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reportedĬomplications during hyperbaric oxygen treatment.
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