Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy

Barotrauma;Ear Clinical Trial

Official title:

Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332211
• Other study ID #: HP-00090947
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: July 12, 2023

Study information

• Verified date: January 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ear(s). 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 27/991 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• New patient requiring HBOT (either inpatient or outpatient)
• Age greater than or equal to 18 years and less than 80 years
• Fluent in English
• Full decision capacity
• Able and medically cleared to swallow a pill

Exclusion Criteria:

• Contraindication to pseudoephedrine (MAOI use, pregnancy, glaucoma, heart disease, allergy to drug class)
• SBP >160
• DBP > 90
• HR >100
• Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
• Prisoner
• Intubated
• Unable take PO meds

Related Conditions & MeSH terms

• Barotrauma
• Barotrauma;Ear

Intervention

Procedure:
• Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions.

Drug:
• Pseudoephedrine 60 MG
administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy
• Placebo oral tablet
administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Requirement of Oxymetalozine rescue for ear pain during Hyperbaric Therapy compression	middle ear barotrauma will be sensed as pain and inability to "clear" the ear to pressure during chamber pressurization. If the patient requires rescue oxymetazoline nasal spray therapy (usual care) they will be counted as having developed middle ear barotrauma.	12 minutes
Secondary	Middle Ear barotrauma documentation based on otoscopy	visual inspection of the tympanic membrane after completion of hyperbaric oxygen therapy by the attending physician and classification based on the Teed score	1 minute
Secondary	Patient description of ear pain	Patients will be asked to provide a numerical scale level of pain before and after hyperbaric therapy. The scale is from 0 to 10.	1 minute