Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04776967 · ClinicalTrials.gov registry record · NA
Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II Prospective Study.
A NA study, sponsored by Northwell Health.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT04776967 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 300 participants.
The verdict
NCT04776967, a NA study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 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. The investigators randomly assigned patient-treatment group exposures to four different time interval and rate (slope) of compression. These total time intervals of compression and rates (slopes) of compression are identical to those used in the Phase I trial. 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 4 compression schedules, similar to ther Phase I trial will be recorded. Patients who are symptomatic and require compression stops (as in the Phase I trial) using a United States Navy Treatment Table 9 (USN-TTN9) during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be analyzed. Analysis using descriptive and inferential statistics will be applied to the patients requiring first stops in the 4 compression profiles. This Phase II study increases the sample size of treatments and they will be combined with the total number of treatments used in the original phase I study. This will increase power to
Interventions
- PROCEDURE Hyperbaric Compression Profile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-09-08 |
| Est. Completion | 2021-02-28 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04776967
The ClinicalTrials.gov registry entry for NCT04776967 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 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 1 intervention - of which Hyperbaric Compression Profile is the first listed.
NCT04776967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04776967 about?
NCT04776967 is a clinical study titled "Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II 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 NCT04776967?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2014-09-08. Estimated completion is 2021-02-28.
What interventions are being tested in trial NCT04776967?
The interventions under investigation include: Hyperbaric Compression Profile (PROCEDURE).
Who is sponsoring clinical trial NCT04776967?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.