Barotrauma in Hyperbaric Oxygen Therapy

Not Applicable

Recruiting

• Conditions: Barotrauma
• Interventions: Drug: Pseudoephedrine Pill; Drug: Placebo

• Registration Number: NCT05697328
• Lead Sponsor: John Muir Health

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.

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.

Study Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-25
• Study Start: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pseudoephedrine	Pseudoephedrine Pill	over the counter pseudoephedrine
Placebo	Placebo	pharmacy created placebo capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of completed compression	1 minute	Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.

Trial Locations

Locations (1)

John Muir Health; 🇺🇸 Walnut Creek, California, United States