Barotrauma in Hyperbaric Oxygen Therapy

Barotrauma Clinical Trial

— HBOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697328
• Other study ID #: 22-10-01
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: January 2026

Study information

• Verified date: March 2023
• Source: John Muir Health
• Contact: Jacinta Showers, RN
• Phone: 9259473212
• Email: jacinta.showers[@]johnmuirhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barotrauma

Intervention

Drug:
• Pseudoephedrine Pill
One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
• Placebo
One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

Locations

Country	Name	City	State
United States	John Muir Health	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
John Muir Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of completed compression	Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.	1 minute