Preventing ear trauma during hyperbaric oxygen therapy with pseudoephedrine
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
This study is testing if taking pseudoephedrine can help prevent ear problems in people receiving hyperbaric oxygen therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | John Muir Health Academic / other |
| Locations | 1 site (Walnut Creek, California) |
| Trial ID | NCT05697328 on ClinicalTrials.gov |
What this trial studies
This research investigates whether pseudoephedrine can prevent middle ear trauma in patients undergoing hyperbaric oxygen therapy (HBOT). Participants will take either a pseudoephedrine pill or a placebo before their HBOT session. Their ears will be examined before and after the therapy, and they will report any ear pain experienced. The study aims to determine the effectiveness of pseudoephedrine in reducing ear-related complications during HBOT.
Who should consider this trial
Good fit: Ideal candidates are new patients aged 18 to 80 who require hyperbaric oxygen therapy and can swallow a pill.
Not a fit: Patients with contraindications to pseudoephedrine or those requiring immediate hyperbaric therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce the incidence of ear trauma in patients receiving hyperbaric oxygen therapy.
How similar studies have performed: While the use of pseudoephedrine in this context is novel, similar studies on preventing barotrauma have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism) * Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class) * Systolic Blood Pressure \>160 * Diastolic Blood Pressure \> 90 * Heart Rate \>100 * Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours. * Prisoner * Intubated * Unable to swallow oral medications
Where this trial is running
Walnut Creek, California
- John Muir Health — Walnut Creek, California, United States (Recruiting)
Study contacts
- Principal investigator: Jacinta Showers, RN — John Muir Health
- Study coordinator: Jacinta Showers, RN
- Email: jacinta.showers@johnmuirhealth.com
- Phone: 9259473212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.