Barotrauma in Hyperbaric Oxygen Therapy

NCT05697328 | Recruiting

• 1 other identifier: 22-10-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Barotrauma

Keywords

hyperbaric oxygen therapy

Outcome Measures

Primary Outcomes (1)

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

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

  45-60 minutes

Secondary Outcomes (1)

• Incidence of completed compression

  1 minute

Study Arms (2)

Pseudoephedrine

EXPERIMENTAL

over the counter pseudoephedrine

Drug: Pseudoephedrine Pill

Placebo

PLACEBO COMPARATOR

pharmacy created placebo capsule

Drug: Placebo

Interventions

Pseudoephedrine Pill DRUG

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

Also known as: Sudafed

Pseudoephedrine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John Muir Health: lead

Study Sites (1)

John Muir Health

Walnut Creek, California, 94598, United States

RECRUITING

MeSH Terms

Conditions

Barotrauma

Interventions

Pseudoephedrine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Jacinta Showers, RN

  John Muir Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacinta Showers, RN

CONTACT

9259473212; jacinta.showers@johnmuirhealth.com

Todd Kessinger, MD, MD

CONTACT

9259473212; todd.kessinger_MD@johnmuirhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind placebo control
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 25, 2023
• Study Start: January 31, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)