NCT05697328 Barotrauma in Hyperbaric Oxygen Therapy
| NCT ID | NCT05697328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | John Muir Health |
| Condition | Barotrauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-01-31 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jacinta Showers, RN
PRINCIPAL INVESTIGATOR
John Muir Health
Frequently Asked Questions
Who can join the NCT05697328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Barotrauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05697328 currently recruiting?
Yes, NCT05697328 is actively recruiting participants. Contact the research team at jacinta.showers@johnmuirhealth.com for enrollment information.
Where is the NCT05697328 trial being conducted?
This trial is being conducted at Walnut Creek, United States.
Who is sponsoring the NCT05697328 clinical trial?
NCT05697328 is sponsored by John Muir Health. The principal investigator is Jacinta Showers, RN at John Muir Health. The trial plans to enroll 90 participants.