Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.
Ear Barotrauma, Middle Ear Disease, Ear Diseases
About this trial
This is an interventional prevention trial for Ear Barotrauma focused on measuring Ear Pressure, Otic Barotrauma, Hyperbaric, Pressure Equalization, O'Neill Grading System, Compression Rate
Eligibility Criteria
Inclusion Criteria:
- Any patient meeting the proper diagnosis and indications to be treated with hyperbaric oxygen.
Exclusion Criteria:
- Any patient with absolute contraindications to hyperbaric oxygen treatment
- Patients with chronic bilateral perforation of the tympanic membrane or;
- A history of prior surgical placement of myringotomy tubes.
Sites / Locations
- Phelps Hospital Northwell HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
15 Minute Non-linear Compression Profile
15 Minute Linear Compression Profile
Compression Profile/Schedule 1 = 15 minute non-linear, Total Time Interval of Compression to treatment depth = 15 minutes Rate (slope) of compression = Non-Linear rate of compression = 2 fsw/min to a depth of 13 fsw, then 3 fsw/min up to a depth of 35 fsw, then 5 fsw/min to arrival at the treatment depth of 45 fsw
Compression Profile/Schedule 2 = 15 minute linear, Total Time Interval of Compression to treatment depth = 15 minutes Rate (slope) of compression = Linear rate of compression = 4.5 fsw/min to arrival at the treatment depth 45 fsw