Investigating how different rates of compression affect ear problems during hyperbaric oxygen treatment
The Effect of Rate (Slope) of Compression on the Incidence of Symptomatic Eustachian Tube Dysfunction and Middle Ear Barotrauma: a Phase III Prospective Study.
This study is testing whether different ways of compressing air can help prevent ear problems in people receiving hyperbaric oxygen treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Sleepy Hollow, New York) |
| Trial ID | NCT04804098 on ClinicalTrials.gov |
What this trial studies
This study examines the impact of varying rates of compression on the incidence of Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) during hyperbaric oxygen therapy. Building on previous findings, the trial will randomly assign patients to receive either a linear or non-linear compression profile over a 15-minute period. Data will be collected prospectively from multiple patients treated as a group to assess the effectiveness of these compression rates in reducing complications. The goal is to determine the optimal compression method that minimizes ETD and MEB occurrences.
Who should consider this trial
Good fit: Ideal candidates include patients who require hyperbaric oxygen treatment and meet the necessary diagnostic criteria.
Not a fit: Patients with absolute contraindications to hyperbaric oxygen treatment or those with chronic ear conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved protocols for hyperbaric oxygen treatment, reducing the risk of ear-related complications for patients.
How similar studies have performed: Previous studies have shown promising results regarding compression profiles in reducing ear complications, but this specific approach is being tested in a larger cohort for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Any patient meeting the proper diagnosis and indications to be treated with hyperbaric oxygen. Exclusion Criteria: * Any patient with absolute contraindications to hyperbaric oxygen treatment * Patients with chronic bilateral perforation of the tympanic membrane or; * A history of prior surgical placement of myringotomy tubes.
Where this trial is running
Sleepy Hollow, New York
- Phelps Hospital Northwell Health — Sleepy Hollow, New York, United States (Recruiting)
Study contacts
- Principal investigator: Owen J O'Neill, MD, MPH — Phelps Hospital Northwell Health
- Study coordinator: Owen J O'Neill, MD, MPH
- Email: ooneill@northwell.edu
- Phone: 914-366-6665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.