Barotrauma in Hyperbaric Oxygen Therapy (HBOT)

John Muir Health

Status: Enrolling

Conditions: Barotrauma

Treatments: Drug: Placebo; Drug: Pseudoephedrine Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT05697328

22-10-01

Details and patient eligibility

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Pseudoephedrine

Experimental group

Description:

over the counter pseudoephedrine

Treatment:

Drug: Pseudoephedrine Pill

Placebo

Placebo Comparator group

Description:

pharmacy created placebo capsule

Treatment:

Drug: Placebo