Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04332211
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Barotrauma;Ear	Procedure: Hyperbaric Oxygen Therapy; Drug: Pseudoephedrine 60 MG; Drug: Placebo oral tablet	Phase 4

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

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 HBOTThe 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: prospective randomized double-blind placebo control
• Primary Purpose: Prevention
• Official Title: Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pseudoephedrine Group Patients randomized to pseudoephedrine prior to hyperbaric therapy	Procedure: 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.; Drug: Pseudoephedrine 60 MG; administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy
Placebo Comparator: Placebo Group Patients randomized to placebo prior to hyperbaric therapy	Procedure: 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.; Drug: Placebo oral tablet; administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Medical Center	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Siamak Moayedi, MD, University of Maryland School of Medicine, Department of Emergency Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Siamak Moayedi, MD, Assistant Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT04332211
• Other Study ID Numbers: HP-00090947
• First Posted: Apr 2, 2020
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Siamak Moayedi, MD, Assistant Professor, University of Maryland, Baltimore: Pseudoephedrine; Hyperbaric oxygen therapy; prophylaxis
• Additional relevant MeSH terms: Barotrauma; Pseudoephedrine; Ephedrine

Study Results

No Results Posted as of Jan 24, 2022