Barotrauma in Hyperbaric Oxygen Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pseudoephedrine Pill, Placebo.
- Who it may be relevant to
- Registry conditions: Barotrauma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Overview
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.
Interventions
- Drug Pseudoephedrine Pill
One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy - Drug Placebo
One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
Primary outcome measures
- Compare changes in self-reported ear pain during hyperbaric oxygen therapy [Time frame: 45-60 minutes]
Secondary outcome measures (1)
- Incidence of completed compression [Time frame: 1 minute]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- John Muir Health — Walnut Creek
Identifiers
NCT: NCT05697328 · 22-10-01