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NCT04804098 · ClinicalTrials.gov registry record · NA
Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.
A NA study, sponsored by Northwell Health.
- Completed
- Registry status
- NA
- Development phase
- 1,553
- Enrollment target
NCT04804098 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 1,553 participants.
The verdict
NCT04804098, a NA study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,553 participants
- Enrollment target
Study Summary
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. Our investigators randomly assign patient-treatment group exposures to two different rates (slopes) of compression. These are limited to the linear versus the non-linear rates (slopes) of compression identical to two of four compression profiles used in the Phase I and Phase II trials. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the compression schedules/compression profiles using an identical 15-minute total time interval of compression but varying in the rate (slope) of compression will be recorded as in the Phase I and II studies. Symptomatic patients who required compression stops (as in the Phase I trial) using a USN TT 9 during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be compared. Statistical analysis using descriptive and Inferential statistics will be applied to the patients requiring first stops in the compression profiles. This will be used to further evaluate the data restricted to the
Interventions
- PROCEDURE Compression Profile/Schedule: 15 minute Non-Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw)
- PROCEDURE Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,553 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2026-05-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04804098
The ClinicalTrials.gov registry entry for NCT04804098 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,553 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Compression Profile/Schedule: 15 minute Non-Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw) is the first listed.
NCT04804098 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04804098 about?
NCT04804098 is a clinical study titled "Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.". Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The P...
What is the current status of trial NCT04804098?
This trial is currently completed. It is a NA study. The enrollment target is 1,553 participants. The study started on 2021-10-01. Estimated completion is 2026-05-05.
What interventions are being tested in trial NCT04804098?
The interventions under investigation include: Compression Profile/Schedule: 15 minute Non-Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw) (PROCEDURE), Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw) (PROCEDURE).
Who is sponsoring clinical trial NCT04804098?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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