Barotrauma in Hyperbaric Oxygen Therapy

NCT05697328 — Not applicable, Recruiting, 90 participants, John Muir Health

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05697328, acronym HBOT
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	90 (Estimated)
Sponsor	John Muir Health (Other)
Conditions	Barotrauma
Interventions	Pseudoephedrine Pill, Placebo (Drug)
Dates	start 2023-01-31, primary completion 2026-07-01 (estimated), completion 2026-07-01 (estimated), first posted 2023-01-25, last updated 2025-08-27
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Detailed description

Subjects will be asked to take a pill (pseudoephedrine or placebo) between 45 and 120 minutes before hyperbaric oxygen therapy. Subjects' ears will be examined before and after therapy and be asked to assess ear pain. There will be no further tests or procedures after completion of therapy session and ear examinations.

+Arms and interventions

Arm	Type	Interventions	Description
Pseudoephedrine	Experimental	Drug: Pseudoephedrine Pill	over the counter pseudoephedrine
Placebo	Placebo comparator	Drug: Placebo	pharmacy created placebo capsule

Pseudoephedrine Pill (Drug), also known as Sudafed: One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
Placebo (Drug): One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

+Outcome measures

Primary outcomes

Compare changes in self-reported ear pain during hyperbaric oxygen therapy [45-60 minutes]: Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy

Secondary outcomes

Incidence of completed compression [1 minute]: Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
John Muir Health	Walnut Creek, California	United States	Recruiting

+Investigators

Jacinta Showers, RN, Principal investigator, John Muir Health