Incidence of Middle Ear Barotrauma In Staged Versus Linear Chamber Compression During Hyperbaric Oxygen Therapy: A Double Blind, Randomized Clinical Trial

None listed

All new patients presenting for hyperbaric oxygen therapy meeting the eligibility criteria will be randomized to either a Staged Compression Protocol (Trial regimen) or a Linear Compression Protocol (standard regimen) during their first hyperbaric chamber compression. Both protocols will achieve the treatment depth of 14 meters within 12-13 minutes. The Staged Protocol has a slightly faster compression rate (1.4 meters/min vs 1.1 meters/min) and has 2 holding stage with no pressure change to allow for patient to catch up with their ear equalization. The rate of compression and depth at the holding stages were choosen based on Boyle's Law calculation that middle ear volume will not change more than 30%. Photographs of the tympanic membranes will be taken pre and post the first session of hyperbaric oxygen therapy. The number of interrupted or aborted treatment and subjective pain score will also be recorded. The photographs will be assessed by a blinded experienced otolaryngologist for middle ear barotrauma grade. Primary outcome is incidence of middle ear barotrauma in staged versus linear protocols. Secondary outcomes are number of interrupted and aborted treatments and patient's comfort from the pain score. The hyperbaric doctors, hyperbaric nurses and the otolargyngologist assessor will all be blinded to protocol used. Only the chamber operator (who is not involved in the clinical management / assessment of the participants) will be aware of the protocol used. Sample size calculation require 50 participants per arm for a power of 80% to detect a difference. The department received on average 10 new patients per month and the research is anticipated to take one year.

No related papers found yet.