RECRUITING

Barotrauma in Hyperbaric Oxygen Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT. Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.

Official Title

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

Quick Facts

Study Start:2023-01-31
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05697328

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * New patient requiring HBOT (either inpatient or outpatient)
  2. * Age greater than or equal to 18 years and less than 80 years
  3. * Fluent in English
  4. * Full decision capacity
  5. * Able and medically cleared to swallow a pill
  1. * Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)
  2. * Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)
  3. * Systolic Blood Pressure \>160
  4. * Diastolic Blood Pressure \> 90
  5. * Heart Rate \>100
  6. * Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
  7. * Prisoner
  8. * Intubated
  9. * Unable to swallow oral medications

Contacts and Locations

Study Contact

Jacinta Showers, RN
CONTACT
9259473212
jacinta.showers@johnmuirhealth.com
Todd Kessinger, MD, MD
CONTACT
9259473212
todd.kessinger_MD@johnmuirhealth.com

Principal Investigator

Jacinta Showers, RN
PRINCIPAL_INVESTIGATOR
John Muir Health

Study Locations (Sites)

John Muir Health
Walnut Creek, California, 94598
United States

Collaborators and Investigators

Sponsor: John Muir Health

  • Jacinta Showers, RN, PRINCIPAL_INVESTIGATOR, John Muir Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-31
Study Completion Date2026-07

Study Record Updates

Study Start Date2023-01-31
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • hyperbaric oxygen therapy

Additional Relevant MeSH Terms

  • Barotrauma