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HBOT: Barotrauma in Hyperbaric Oxygen Therapy

Sponsor
John Muir Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05697328
Collaborator
(none)
90
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pseudoephedrine Pill
  • Drug: Placebo
 N/A

Detailed Description

Subjects will be asked to take a pill (pseudoephedrine or placebo) between 45 and 120 minutes before hyperbaric oxygen therapy. Subjects' ears will be examined before and after therapy and be asked to assess ear pain. There will be no further tests or procedures after completion of therapy session and ear examinations.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective randomized double-blind placebo control study design (enrollment ratio 1:1)prospective randomized double-blind placebo control study design (enrollment ratio 1:1)
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind placebo control
Primary Purpose:
Prevention
Official Title:
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pseudoephedrine

over the counter pseudoephedrine

Drug: Pseudoephedrine Pill
One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
Other Names:
  • Sudafed

    		•
    Placebo Comparator: Placebo

    pharmacy created placebo capsule

    Drug: Placebo
    One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

    Outcome Measures

    Primary Outcome Measures

    1. Compare changes in self-reported ear pain during hyperbaric oxygen therapy [45-60 minutes]

      Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy

    Secondary Outcome Measures

    1. Incidence of completed compression [1 minute]

      Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.

    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:

    • Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)

    • Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)

    • Systolic Blood Pressure >160

    • Diastolic Blood Pressure > 90

    • Heart Rate >100

    • Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.

    • Prisoner

    • Intubated

    • Unable to swallow oral medications

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • John Muir Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jacinta Showers, Principal Investigator, John Muir Health
    ClinicalTrials.gov Identifier:
    NCT05697328
    Other Study ID Numbers:
    • 22-10-01
    First Posted:
    Jan 25, 2023
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Jacinta Showers, Principal Investigator, John Muir Health
    hyperbaric oxygen therapy
    Additional relevant MeSH terms:
    Barotrauma
    Pseudoephedrine
    Ephedrine

    Study Results

    No Results Posted as of Jan 25, 2023