Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04332211
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2020-03-28
Brief Title:
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hyperbaric oxygen therapy HBOT utilizes 100 oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning The most commonly associated complication of HBOT is middle ear barotrauma MEB which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear Patients experiencing MEB usually feel pressure or pain in their ears The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain vertigo and tympanic membrane rupture The incidence of MEB depending on the definition used is between 2-45 The severe discomfort associated with MEB sometimes causes HBOT to be postponed or abandoned Last year 27991 treatments at our Center for Hyperbaric and Dive Medicine were aborted due to MEB Currently there is no objective criteria for predicting which patients will experience these complications nor is there consensus on effective prevention measures At our facility oxymetazoline a topical nasal decongestant is the standard rescue medication administered for patients that have symptoms of MEB during HBOT This is despite two negative studies showing that this medication does not work any better than placebo Other studies involving scuba divers and airplane travelers showed that oral pseudoephedrine is effective in decreasing MEB However the use of pseudoephedrine for patients undergoing HBOT has not been studied The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT
Detailed Description:
Aim 1 To investigate the efficacy of pre-treatment with oral pseudoephedrine 60mg for decreasing MEB during HBOT
Hypothesis Patients randomized to pseudoephedrine will have a lesser need for oxymetazoline rescue therapy while being compressed They will also report less ear pain once at pressure compared to patients receiving placebo
Aim 2 To measure the incidence of MEB during HBOT The investigators will also identify factors age gender medical history that could predispose an individual to developing MEB during HBOT
Hypothesis The incidence of MEB defined as requiring stopping compression of the chamber and oxymetazoline rescue will be greater than 30 Female sex age above 60 and prior history of ear conditions will be associated with development of MEB
Hypothesis Patients randomized to pseudoephedrine will have a lesser need for oxymetazoline rescue therapy while being compressed They will also report less ear pain once at pressure compared to patients receiving placebo
Aim 2 To measure the incidence of MEB during HBOT The investigators will also identify factors age gender medical history that could predispose an individual to developing MEB during HBOT
Hypothesis The incidence of MEB defined as requiring stopping compression of the chamber and oxymetazoline rescue will be greater than 30 Female sex age above 60 and prior history of ear conditions will be associated with development of MEB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None