Barotrauma in Hyperbaric Oxygen Therapy
ConditionBarotrauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Muir Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pseudoephedrine Pill
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov