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

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.

Study Overview

• Status: Completed
• Conditions: Barotrauma;Ear
• Intervention / Treatment: Procedure: Hyperbaric Oxygen Therapy; Drug: Pseudoephedrine 60 MG; Drug: Placebo oral tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Siamak Moayedi, MD; Phone Number: 4103286152; Email: Mak.moayedi@som.umaryland.edu
• Study Contact Backup: Name: Kinjal Sethuraman, MD; Phone Number: 4103286152; Email: Kinjal.Sethuraman@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pseudoephedrine Group; Patients randomized to pseudoephedrine prior to hyperbaric therapy	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 Comparator: Placebo Group; Patients randomized to placebo prior to hyperbaric therapy	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: Placebo oral tablet; administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Siamak Moayedi, MD, University of Maryland School of Medicine, Department of Emergency Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: March 28, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: prophylaxis; Hyperbaric oxygen therapy; Pseudoephedrine
• Additional Relevant MeSH Terms: Wounds and Injuries; Barotrauma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: HP-00090947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes