Barotrauma in Hyperbaric Oxygen Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Barotrauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized double-blind placebo control study design (enrollment ratio 1:1)

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double-blind placebo control

Study Groups

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Pseudoephedrine

over the counter pseudoephedrine

Group Type EXPERIMENTAL

Pseudoephedrine Pill

Intervention Type DRUG

One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

Placebo

pharmacy created placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

Interventions

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Pseudoephedrine Pill

One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

Intervention Type DRUG

Placebo

One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

Intervention Type DRUG

Other Intervention Names

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Sudafed

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No