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NCT Number: NCT04332211

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.

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Key information

Conditions

Barotrauma;Ear

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy

Procedure

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

Pseudoephedrine 60 MG

Drug

administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy

Placebo oral tablet

Drug

administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy

Primary outcomes

  1. Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression

    Time frame: 12 minutes

    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.

Secondary outcomes

  1. Middle Ear Barotrauma Documentation Based on Otoscopy

    Time frame: 1 minute

    visual inspection of the tympanic membrane after completion of hyperbaric oxygen therapy by the attending physician and classification based on the Teed score. We are only measuring no injury versus any injury.

  2. Patient Description of Ear Pain

    Time frame: 1 minute

    Patients will be asked to provide a numerical scale level of pain before and after hyperbaric therapy. The scale is from 0 to 10. We only are interested in no pain versus presence of any pain.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 2, 2020
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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