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

NCT04332211 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HP-00090947
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Barotrauma;Ear

Keywords

Pseudoephedrine; Hyperbaric oxygen therapy; prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Middle Ear Barotrauma Documentation Based on Otoscopy

  1 minute

• Patient Description of Ear Pain

  1 minute

Study Arms (2)

Pseudoephedrine Group

EXPERIMENTAL

Patients randomized to pseudoephedrine prior to hyperbaric therapy

Procedure: Hyperbaric Oxygen Therapy; Drug: Pseudoephedrine 60 MG

Placebo Group

PLACEBO COMPARATOR

Patients randomized to placebo prior to hyperbaric therapy

Procedure: Hyperbaric Oxygen Therapy; Drug: Placebo oral tablet

Interventions

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.

Placebo Group; Pseudoephedrine Group

Pseudoephedrine 60 MG DRUG

administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy

Pseudoephedrine Group

Placebo oral tablet DRUG

administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation; Pseudoephedrine

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Siamak Moayedi MD
• Organization: University of Maryland School of Medicine, Department of Emergency Medicine

Mak.Moayedi@som.umaryland.edu

4103288025

Study Officials

• Siamak Moayedi, MD

  University of Maryland School of Medicine, Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: prospective randomized double-blind placebo control
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 2, 2020
• Study Start: May 1, 2021
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)