Barotrauma;Ear
Conditions
Keywords
Pseudoephedrine, Hyperbaric oxygen therapy, prophylaxis
Brief 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. 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.
Interventions
PROCEDUREHyperbaric 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.
DRUGPseudoephedrine 60 MG
administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy
DRUGPlacebo oral tablet
administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
prospective randomized double-blind placebo control
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Middle Ear Barotrauma Documentation Based on Otoscopy | 1 minute | 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. |
| Patient Description of Ear Pain | 1 minute | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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 | 41 |
| Total | 81 |
Baseline characteristics
| Characteristic | Placebo Group | Total | Pseudoephedrine Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 81 Participants | 40 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 12 | 54.5 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 41 Participants | 81 Participants | 40 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 41 participants | 81 participants | 40 participants |
| Sex: Female, Male Female | 17 Participants | 27 Participants | 10 Participants |
| Sex: Female, Male Male | 24 Participants | 54 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 41 |
| other Total, other adverse events | 0 / 40 | 0 / 41 |
| serious Total, serious adverse events | 0 / 40 | 0 / 41 |
Outcome results
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.
Time frame: 12 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pseudoephedrine Group | Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression | 8 Participants |
| Placebo Group | Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression | 11 Participants |
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.
Time frame: 1 minute
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pseudoephedrine Group | Middle Ear Barotrauma Documentation Based on Otoscopy | 6 Participants |
| Placebo Group | Middle Ear Barotrauma Documentation Based on Otoscopy | 11 Participants |
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.
Time frame: 1 minute
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pseudoephedrine Group | Patient Description of Ear Pain | 5 Participants |
| Placebo Group | Patient Description of Ear Pain | 12 Participants |