Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.

NCT04804098 | Unknown

• 1 other identifier: Compression Hyperbaric III
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 rate of compression (linear vs. non-linear) and whether this is associated with the number of compression holds. The 15-minute total time interval of compression will be identical in both compression profiles studied since this was found to be the total time interval of compression with the least number of treatment stops/holds in the phase I and phase II studies.

Conditions

Ear Barotrauma; Middle Ear Disease; Ear Diseases; Pressure Injury; Eustachian Tube Dysfunction; Middle Ear; Injury; Middle Ear Barotrauma

Keywords

Ear Pressure; Otic Barotrauma; Hyperbaric; Pressure Equalization; O'Neill Grading System; Compression Rate

Outcome Measures

Primary Outcomes (2)

• Hyperbaric oxygen chamber Treatment Stops/Holds during compression

  Hyperbaric oxygen treatment (HBOT) protocols include a compression phase. Pressure is increased until final treatment pressure is achieved. Pressure changes vary between 14.7 psi to 35 psi. Patients experience symptoms of pain or pressure in the middle ear space because they cannot clear middle ear pressure upon compression of the chamber. Pressure symptoms are time related but not as yet slope related. Using varying rates of pressure may decrease discomfort related to clearing middle ear pressure known as Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB). They are the most common adverse effects of HBOT. The authors believe a change in slope rate of compression may decrease the occurrence of stops and decrease the incidence of ETD and MEB during HBOT. Decreasing rate of compression may further mitigate risk and decrease the incidence of symptomatic ETD and MEB.

  Patients are assessed during each hyperbaric chamber compression until reaching treatment pressure/depth daily throughout the entire treatment course that varies based on diagnosis over 4-12 weeks

• Severity of ETD/MEB when a patient has a stop/hold during compression

  Photo otoscopy and the severity of eustachian tub dysfunction and/or middle ear barotrauma will be defined using the O'Neill Grading System when a patient experiences a stop or hold during the compression phase of hyperbaric oxygen treatment. O'Neill Grading System: 0 = Symptoms of Eustachian tube dysfunction with no objective signs of barotrauma on otoscopy 1. = Objective evidence indicating the presence of erythema, air trapping or serous/serosanguinous effusion 2. = Any frank bleeding in the middle ear space, tympanic membrane, external ear canal, or perforation

  Patients are assessed during each hyperbaric chamber compression until reaching treatment pressure/depth daily throughout the entire treatment course that varies based on diagnosis over 4-12 weeks

Study Arms (2)

15 Minute Non-linear Compression Profile

ACTIVE COMPARATOR

Compression Profile/Schedule 1 = 15 minute non-linear, Total Time Interval of Compression to treatment depth = 15 minutes Rate (slope) of compression = Non-Linear rate of compression = 2 fsw/min to a depth of 13 fsw, then 3 fsw/min up to a depth of 35 fsw, then 5 fsw/min to arrival at the treatment depth of 45 fsw

Procedure: Compression Profile/Schedule: 15 minute Non-Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw)

15 Minute Linear Compression Profile

ACTIVE COMPARATOR

Compression Profile/Schedule 2 = 15 minute linear, Total Time Interval of Compression to treatment depth = 15 minutes Rate (slope) of compression = Linear rate of compression = 4.5 fsw/min to arrival at the treatment depth 45 fsw

Procedure: Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw)

Interventions

Compression Profile/Schedule: 15 minute Non-Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw) PROCEDURE

Patients will be compressed according to the 15 minute non-linear compression schedule on a rotating daily basis. A total of 2 randomized hyperbaric treatment compression profiles (accepted standards of care) will be alternated over the patients course of treatment on a daily basis daily to the prescribed treatment depth. There are multiple patients exposed during the compression profile randomized for that day. The patients are exposed over the course of 4-12 weeks using one of the two compression protocols to be studied on alternating days.

Also known as: Hyperbaric Compression Schedule 15 min non-linear

15 Minute Non-linear Compression Profile

Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw) PROCEDURE

Patients will be compressed according to the 15 minute linear compression schedule on a rotating daily basis with compression. A total of 2 randomized hyperbaric treatment compression profiles (accepted standards of care) will be alternated over the patients course of treatment on a daily basis daily to the prescribed treatment depth. There are multiple patients exposed during the compression profile randomized for that day. The patients are exposed over the course of 4-12 weeks using one of the two compression protocols to be studied on alternating days.

Also known as: Hyperbaric Compression Schedule 15 min linear

15 Minute Linear Compression Profile

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Any patient meeting the proper diagnosis and indications to be treated with hyperbaric oxygen.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Phelps Hospital Northwell Health

Sleepy Hollow, New York, 10591, United States

RECRUITING

Related Publications (17)

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  PMID: 16772053 BACKGROUND

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  PMID: 25558542 BACKGROUND

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  PMID: 31051054 BACKGROUND

MeSH Terms

Conditions

Ear Diseases; Pressure Ulcer; Wounds and Injuries

Interventions

Appointments and Schedules

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Officials

• Owen J O'Neill, MD, MPH

  Phelps Hospital Northwell Health

  PRINCIPAL INVESTIGATOR

• David Dayya, DO, PhD, MPH

  Phelps Hospital Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Owen J O'Neill, MD, MPH

CONTACT

914-366-6665; ooneill@northwell.edu

David Dayya, DO, PhD, MPH

CONTACT

914 - 366 - 3690; ddayya1@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director Division of Undersea & Hyperbaric Medicine

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 18, 2021
• Study Start: September 20, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Post publication
• Access Criteria: Contact Primary Investgators by Email

Locations

US (1)