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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pseudoephedrine Group | Experimental | Patients randomized to pseudoephedrine prior to hyperbaric therapy |
|
| Placebo Group | Placebo Comparator | Patients randomized to placebo prior to hyperbaric therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | Procedure | Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 minute |
| Patient Description of Ear Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siamak Moayedi, MD | University of Maryland School of Medicine, Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pseudoephedrine Group | Patients randomized to pseudoephedrine prior to hyperbaric therapy Hyperbaric Oxygen Therapy: 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 MG: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy |
| FG001 | Placebo Group | Patients randomized to placebo prior to hyperbaric therapy Hyperbaric Oxygen Therapy: Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions. Placebo oral tablet: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
analyzed population were all enrolled subjects who took the study pill within the appropriate time and underwent hyperbaric oxygen therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pseudoephedrine Group | Patients randomized to pseudoephedrine prior to hyperbaric therapy Hyperbaric Oxygen Therapy: 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 MG: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 minutes |
|
4 hours
no adverse events were expected and none occurred
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pseudoephedrine Group | Patients randomized to pseudoephedrine prior to hyperbaric therapy Hyperbaric Oxygen Therapy: 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 MG: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siamak Moayedi MD | University of Maryland School of Medicine, Department of Emergency Medicine | 4103288025 | Mak.Moayedi@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2022 | Dec 29, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2023 | Dec 29, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D011412 | Propanolamines |
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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
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prospective randomized double-blind placebo control
| Pseudoephedrine 60 MG | Drug | administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy |
|
| Placebo oral tablet | Drug | administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy |
|
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. |
| 1 minute |
| BG001 | Placebo Group | Patients randomized to placebo prior to hyperbaric therapy Hyperbaric Oxygen Therapy: Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions. Placebo oral tablet: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo Group |
Patients randomized to placebo prior to hyperbaric therapy Hyperbaric Oxygen Therapy: Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions. Placebo oral tablet: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 minute |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 minute |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo Group | Patients randomized to placebo prior to hyperbaric therapy Hyperbaric Oxygen Therapy: Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions. Placebo oral tablet: administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy | 0 | 41 | 0 | 41 | 0 | 41 |
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| D000605 |
| Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |