Barotrauma;EarPhase 4NCT04332211
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
A Phase 4 study testing Hyperbaric Oxygen Therapy and Pseudoephedrine 60 MG in people with Barotrauma;Ear, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barotrauma;Ear
- What is being tested?
- Hyperbaric Oxygen Therapy and Pseudoephedrine 60 MG
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 12 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to pseudoephedrine (MAOI use, pregnancy, glaucoma, heart disease, allergy to drug class)
- SBP >160
- DBP > 90
- HR >100
- Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
- Prisoner
- Intubated
- Unable take PO meds
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. The most commonly associated complication of HBOT is middle ear barotrauma (MEB) which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear. Patients experiencing MEB usually feel pressure or pain in their ear(s). The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain, vertigo and tympanic membrane rupture. The incidence of MEB, depending on the definition used is between 2-45%. The severe discomfort associated with MEB sometimes causes HBOT to be postponed or abandoned. Last year 27/991 treatments at our Center for Hyperbaric and Dive Medicine were aborted due to MEB. Currently there is no objective criteria for predicting which patients will experience these complications, nor is there consensus on effective prevention measures. At our facility, oxymetazoline, a topical nasal decongestant, is the standard rescue medication administered for patients that have symptoms of MEB during HBOT. This is despite two negative studies showing that this medication does not work any better than placebo. Other studies involving scuba divers and airplane travelers showed that oral pseudoephedrine is effective in decreasing MEB. However, the use of pseudoephedrine for patients undergoing HBOT has not been studied. The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT.
Read the detailed description
Aim 1: To investigate the efficacy of pre-treatment with oral pseudoephedrine 60mg for decreasing MEB during HBOT.
Hypothesis: Patients randomized to pseudoephedrine will have a lesser need for oxymetazoline rescue therapy while being compressed. They will also report less ear pain once at pressure compared to patients receiving placebo.
Aim 2: To measure the incidence of MEB during HBOT. The investigators will also identify factors (age, gender, medical history) that could predispose an individual to developing MEB during HBOT.
Hypothesis: The incidence of MEB defined as requiring stopping compression of the chamber and oxymetazoline rescue will be greater than 30%. Female sex, age above 60, and prior history of ear conditions will be associated with development of MEB.
- Conditions
- Barotrauma;Ear
- Being tested
- Hyperbaric Oxygen Therapy, Pseudoephedrine 60 MG, Placebo oral tablet
- Keywords
- Pseudoephedrine, Hyperbaric oxygen therapy, prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions.
Pseudoephedrine 60 MGDrug
administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy
Placebo oral tabletDrug
administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Pseudoephedrine Group | Experimental | Patients randomized to pseudoephedrine prior to hyperbaric therapy Receives: Procedure: Hyperbaric Oxygen Therapy; Drug: Pseudoephedrine 60 MG |
| Placebo Group | Placebo comparator | Patients randomized to placebo prior to hyperbaric therapy Receives: Procedure: Hyperbaric Oxygen Therapy; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression
middle ear barotrauma will be sensed as pain and inability to "clear" the ear to pressure during chamber pressurization. If the patient requires rescue oxymetazoline nasal spray therapy (usual care) they will be counted as having developed middle ear barotrauma.
Measured: 12 minutes
Secondary outcomes (2)
Middle Ear Barotrauma Documentation Based on Otoscopy
visual inspection of the tympanic membrane after completion of hyperbaric oxygen therapy by the attending physician and classification based on the Teed score. We are only measuring no injury versus any injury.
Measured: 1 minute
Patient Description of Ear Pain
Patients will be asked to provide a numerical scale level of pain before and after hyperbaric therapy. The scale is from 0 to 10. We only are interested in no pain versus presence of any pain.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 May 2021
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Barotrauma;EarStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will employ a prospective randomized double-blind placebo control study design (enrollment ratio 1:1) to compare whether pseudoephedrine is more effective than placebo in preventing barotrauma during HBOT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siamak Moayedi, MD, University of Maryland, Baltimore
- Investigators
- Siamak Moayedi, MD, Principal investigator, University of Maryland School of Medicine, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332211
- Sponsor's protocol ID
- HP-00090947
- Status last verified
- Dec 2024
- First submitted
- 28 Mar 2020
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
- ClinicalTrials.gov ID
- NCT04332211
- Acronym / sponsor ID
- HP-00090947
- Conditions
- Barotrauma;Ear
- Keywords
- Pseudoephedrine, Hyperbaric oxygen therapy, prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. The most commonly associated complication of HBOT is middle ear barotrauma (MEB) which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear. Patients experiencing MEB usually feel pressure or pain in their ear(s). The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain, vertigo and tympanic membrane rupture. The incidence of MEB, depending on the definition used is between 2-45%. The severe discomfort associated with MEB sometimes causes HBOT to be postponed or abandoned. Last year 27/991 treatments at our Center for Hyperbaric and Dive Medicine were aborted due to MEB. Currently there is no objective criteria for predicting which patients will experience these complications, nor is there consensus on effective prevention measures. At our facility, oxymetazoline, a topical nasal decongestant, is the standard rescue medication administered for patients that have symptoms of MEB during HBOT. This is despite two negative studies showing that this medication does not work any better than placebo. Other studies involving scuba divers and airplane travelers showed that oral pseudoephedrine is effective in decreasing MEB. However, the use of pseudoephedrine for patients undergoing HBOT has not been studied. The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT.
Detailed description
Aim 1: To investigate the efficacy of pre-treatment with oral pseudoephedrine 60mg for decreasing MEB during HBOT.
Hypothesis: Patients randomized to pseudoephedrine will have a lesser need for oxymetazoline rescue therapy while being compressed. They will also report less ear pain once at pressure compared to patients receiving placebo.
Aim 2: To measure the incidence of MEB during HBOT. The investigators will also identify factors (age, gender, medical history) that could predispose an individual to developing MEB during HBOT.
Hypothesis: The incidence of MEB defined as requiring stopping compression of the chamber and oxymetazoline rescue will be greater than 30%. Female sex, age above 60, and prior history of ear conditions will be associated with development of MEB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will employ a prospective randomized double-blind placebo control study design (enrollment ratio 1:1) to compare whether pseudoephedrine is more effective than placebo in preventing barotrauma during HBOT
| Arm | Type | Receives |
|---|---|---|
| Pseudoephedrine Group | Experimental | Procedure: Hyperbaric Oxygen Therapy, Drug: Pseudoephedrine 60 MGPatients randomized to pseudoephedrine prior to hyperbaric therapy |
| Placebo Group | Placebo comparator | Procedure: Hyperbaric Oxygen Therapy, Drug: Placebo oral tabletPatients randomized to placebo prior to hyperbaric therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Contraindication to pseudoephedrine (MAOI use, pregnancy, glaucoma, heart disease, allergy to drug class)
- SBP >160
- DBP > 90
- HR >100
- Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions. | Procedure or surgery | Placebo Group, Pseudoephedrine Group |
| Pseudoephedrine 60 MGadminister either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy | Drug | Pseudoephedrine Group |
| Placebo oral tabletadminister either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy | Drug | Placebo Group |
Primary outcome
Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression
Time frame: 12 minutes
middle ear barotrauma will be sensed as pain and inability to "clear" the ear to pressure during chamber pressurization. If the patient requires rescue oxymetazoline nasal spray therapy (usual care) they will be counted as having developed middle ear barotrauma.
2 secondary outcomes
Middle Ear Barotrauma Documentation Based on Otoscopy
Time frame: 1 minute
Patient Description of Ear Pain
Time frame: 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siamak Moayedi, MD principal investigator
University of Maryland School of Medicine, Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric Oxygen Therapy and Pseudoephedrine 60 MG in people with Barotrauma;Ear, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression (time frame: 12 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.