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Barotrauma in Hyperbaric Oxygen Therapy (HBOT)

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ClinicalTrials.gov Identifier: NCT05697328
Recruitment Status : Recruiting
First Posted : January 25, 2023
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Jacinta Showers, John Muir Health

Study Description
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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
Barotrauma Drug: Pseudoephedrine Pill Drug: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Actual Study Start Date : January 31, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Compare changes in self-reported ear pain during hyperbaric oxygen therapy [ Time Frame: 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 [ Time Frame: 1 minute ]
    Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05697328


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

Locations
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United States, California
John Muir Health Recruiting
Walnut Creek, California, United States, 94598
Contact: Jacinta Showers, RN    925-947-3212    jacinta.showers@johnmuirhealth.com   
Contact: Todd Kessinger, MD    9259473212    todd.kessinger_MD@johnmuirhealth.com   
Principal Investigator: Jacinta Showers, RN         
Sub-Investigator: Todd Kessinger, MD         
Sponsors and Collaborators
John Muir Health
Investigators
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Principal Investigator: Jacinta Showers, RN John Muir Health
More Information
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Responsible Party: Jacinta Showers, Principal Investigator, John Muir Health
ClinicalTrials.gov Identifier: NCT05697328    
Other Study ID Numbers: 22-10-01
First Posted: January 25, 2023    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, John Muir Health:
hyperbaric oxygen therapy
Additional relevant MeSH terms:
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Barotrauma
Wounds and Injuries
Pseudoephedrine
Ephedrine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action