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NCT Number: NCT05697328

Barotrauma in Hyperbaric Oxygen Therapy

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.

Recruiting

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Key information

Conditions

Barotrauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Muir Health

Walnut Creek, California, 94598, United States

Location status: Recruiting

Location contact

Jacinta Showers, RN

CONTACT

[email protected]

9259473212

Jacinta Showers, RN

PRINCIPAL_INVESTIGATOR

Todd Kessinger, MD

CONTACT

[email protected]

9259473212

Todd Kessinger, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pseudoephedrine Pill

Drug

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

Other names: Sudafed

Placebo

Drug

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

Primary outcomes

  1. Compare changes in self-reported ear pain during hyperbaric oxygen therapy

    Time frame: 45-60 minutes

    Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy

Secondary outcomes

  1. Incidence of completed compression

    Time frame: 1 minute

    Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacinta Showers, RN

CONTACT

[email protected]

9259473212

Todd Kessinger, MD, MD

CONTACT

[email protected]

9259473212

Sponsors and collaborators

Lead sponsor

John Muir Health

Other

Registry information

Official study title

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

Acronym: HBOT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2023
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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