Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05697328

Barotrauma in Hyperbaric Oxygen Therapy

Led by John Muir Health · Updated on 2025-08-27

90

Participants Needed

1

Research Sites

178 weeks

Total Duration

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AI-Summary

What this Trial Is About

The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT. Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.

CONDITIONS

Official Title

Barotrauma in Hyperbaric Oxygen Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • New patient requiring hyperbaric oxygen therapy (either inpatient or outpatient)
  • Age 18 years or older and less than 80 years
  • Fluent in English
  • Full decision-making capacity
  • Able and medically cleared to swallow a pill
Not Eligible

You will not qualify if you...

  • Enrollment would delay hyperbaric therapy more than 30 minutes for emergency cases (e.g., Central Retinal Arterial Occlusion, Carbon Monoxide poisoning, Air Gas Embolism)
  • Contraindications to pseudoephedrine including use of monoamine oxidase inhibitors (MAOI), pregnancy, glaucoma, heart disease, or allergy to the drug class
  • Systolic blood pressure greater than 160
  • Diastolic blood pressure greater than 90
  • Heart rate greater than 100
  • Use of decongestants, antihistamines, pseudoephedrine, nasal steroids, or oxymetazoline within 12 hours
  • Prisoner status
  • Intubated
  • Unable to swallow oral medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

John Muir Health

Walnut Creek, California, United States, 94598

Actively Recruiting

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Research Team

J

Jacinta Showers, RN

CONTACT

T

Todd Kessinger, MD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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