Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.

Launched by NORTHWELL HEALTH · Mar 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the speed at which pressure is applied during hyperbaric oxygen treatment affects the development of ear problems, specifically Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB). These issues can occur when people undergo this treatment for various conditions related to ear health. The researchers want to find out the best way to apply pressure to minimize these complications. Participants will be part of groups that receive the treatment at different rates of pressure change, and their experiences will be closely monitored.

To be eligible for this study, patients must be diagnosed with a condition that requires hyperbaric oxygen treatment, but they should not have certain serious ear issues or previous surgeries that could complicate their participation. Those who join the trial can expect to receive treatment in a controlled environment while their symptoms are tracked and assessed. The goal is to determine which method of applying pressure leads to fewer problems, helping to improve the safety and comfort of future treatments.

Gender

ALL

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.