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Barotrauma in Hyperbaric Oxygen Therapy (HBOT)

Primary Purpose

Barotrauma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pseudoephedrine Pill
Placebo
Sponsored by
John Muir Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Barotrauma focused on measuring hyperbaric oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John Muir HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pseudoephedrine

Placebo

Arm Description

over the counter pseudoephedrine

pharmacy created placebo capsule

Outcomes

Primary Outcome Measures

Compare changes in self-reported ear pain during hyperbaric oxygen therapy
Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy

Secondary Outcome Measures

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

Full Information

First Posted
December 26, 2022
Last Updated
March 8, 2023
Sponsor
John Muir Health
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1. Study Identification

Unique Protocol Identification Number
NCT05697328
Brief Title
Barotrauma in Hyperbaric Oxygen Therapy
Acronym
HBOT
Official Title
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
John Muir Health

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barotrauma
Keywords
hyperbaric oxygen therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized double-blind placebo control study design (enrollment ratio 1:1)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind placebo control
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pseudoephedrine
Arm Type
Experimental
Arm Description
over the counter pseudoephedrine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
pharmacy created placebo capsule
Intervention Type
Drug
Intervention Name(s)
Pseudoephedrine Pill
Other Intervention Name(s)
Sudafed
Intervention Description
One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
Primary Outcome Measure Information:
Title
Compare changes in self-reported ear pain during hyperbaric oxygen therapy
Description
Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy
Time Frame
45-60 minutes
Secondary Outcome Measure Information:
Title
Incidence of completed compression
Description
Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacinta Showers, RN
Phone
9259473212
Email
jacinta.showers@johnmuirhealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Kessinger, MD, MD
Phone
9259473212
Email
todd.kessinger_MD@johnmuirhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacinta Showers, RN
Organizational Affiliation
John Muir Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Muir Health
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacinta Showers, RN
Phone
925-947-3212
Email
jacinta.showers@johnmuirhealth.com
First Name & Middle Initial & Last Name & Degree
Todd Kessinger, MD
Phone
9259473212
Email
todd.kessinger_MD@johnmuirhealth.com
First Name & Middle Initial & Last Name & Degree
Jacinta Showers, RN
First Name & Middle Initial & Last Name & Degree
Todd Kessinger, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Barotrauma in Hyperbaric Oxygen Therapy

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