Status:
COMPLETED
Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II Prospective Study.
Lead Sponsor:
Northwell Health
Conditions:
Eustachian Tube Dysfunction
Middle Ear Barotrauma
Eligibility:
All Genders
Phase:
NA
Brief Summary
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistica...
Detailed Description
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The investigators Phase I study data was the first to demonstrat...
Eligibility Criteria
Inclusion
- Any patient meeting the indications for hyperbaric oxygen treatment.
- \-
Exclusion
- Any patient with absolute contraindications to hyperbaric oxygen treatment, chronic bilateral perforation of the tympanic membrane or prior bilateral myringotomy tube placement.
- \-
Key Trial Info
Start Date :
September 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04776967
Start Date
September 8 2014
End Date
February 28 2021
Last Update
August 19 2021
Active Locations (1)
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1
Phelps Hospital Northwell Health
Sleepy Hollow, New York, United States, 10591