Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II Prospective Study.

NCT04776967 | Completed

• 1 other identifier: Compression Hyperbaric II
• 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. 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 facilitate detailed descriptive analysis and to determine if the findings are robust in the phase I study.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Compression stops or holds during the compression phase of hyperbaric oxygen treatments

  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. Pressure symptoms may be time and/or slope related. Using varying rates of pressure may decrease discomfort related to clearing middle ear pressure; Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB), the most common adverse effects of HBOT. The authors believe a slower rate or slope 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

• Assessing the severity of Eustachian tube dysfunction and middle ear barotrauma after using various compression rates and slopes of compression during hyperbaric oxygen treatment via direct video otoscopy

  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 of increased erythema, air trapping or serous/serosanguinous effusion 2. = Any frank bleeding in the middle ear space, tympanic membrane or 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 (4)

Compression Profile 4

ACTIVE COMPARATOR

Compression Profile/Schedule 4 = 10 minute linear, Total Time Interval of Compression to treatment depth = 10 minutes, Rate (slope) of compression = Linear rate of compression = 4.5 fsw/min to arrival at treatment depth 45 fsw

Procedure: Hyperbaric Compression Profile

Compression Profile 3

ACTIVE COMPARATOR

Compression Profile/Schedule 3 = 10 minute non-linear, Total Time Interval of Compression to treatment depth = 10 minutes Rate (slope) of compression = Non-Linear rate of compression = 3 fsw/min to a depth of 17 fsw, then 5 fsw/min up to a depth of 38.5 fsw, then 6.5 fsw/min to arrival at the treatment depth of 45 fsw

Procedure: Hyperbaric Compression Profile

Compression Profile 2

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: Hyperbaric Compression Profile

Compression Profile 1

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: Hyperbaric Compression Profile

Interventions

Hyperbaric Compression Profile PROCEDURE

A total of 4 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.

Also known as: Hyperbaric Compression Schedule

Compression Profile 1; Compression Profile 2; Compression Profile 3; Compression Profile 4

Eligibility Criteria

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Phelps Hospital Northwell Health

Sleepy Hollow, New York, 10591, United States

Location

Related Publications (2)

• 1. Beuerlein M, Nelson RN, DB W. Inner and middle ear hyperbaric oxygen induced barotrauma. The Laryngoscope. 1997;107(10):1350-6. 2. EM C. Side effects of hyperbaric oxygen therapy. Undersea & Hyperbaric Medicine : Journal of the Undersea and Hyperbaric Medical Society, Inc. 2014;41(3):253-7. 3. Heyboer M, Wojcik SM, Grant WD, Chambers P, Jennings S, P A. Middle ear barotrauma in hyperbaric oxygen therapy. Undersea & Hyperbaric Medicine Journal of the Undersea and Hyperbaric Medical Society, Inc, . 2014;41(5):393-7. 4. Lima MA, Farage L, Cury MC, FJ B. Update on middle ear barotrauma after hyperbaric oxygen therapy-insights on pathophysiology. International Archives of Otorhinolaryngology. 2014;18(2):204-9. 5. Ng AWA, Muller R, J O. Incidence of middle ear barotrauma in staged versus linear chamber compression during hyperbaric oxygen therapy: a double blinded, randomized controlled trial. Undersea Hyperb Med: Journal of the Undersea and Hyperbaric Medical Society, Inc. 2017;44(2):101-7. 6. Plafki C, Peters P, Almeling M, Welslau W, R B. Complications and side effects of hyperbaric oxygen therapy. Aviation, Space, and Environmental Medicine. 2000;71(2):119-24. 7. Toklu AS, Shupak A, Yildiz S, Aktas S, Ertracht O, Ay H, et al. Aural barotrauma in submarine escape: is mastoid pneumatization of significance? The Laryngoscope. 2005; 115(7):1305-9. 8. Vahidova D, Sen P, Papesch M, Zein-Sanchez MP, PH M. Does the slow compression technique of hyperbaric oxygen therapy decrease the incidence of middle ear barotrauma? J Laryngol Otol. 2006;120(6):446-9. 9. Varughese L, O'Neill OJ, Marker J, Smykowski E, Dayya D. The Effect of Compression Rate and Slope on the Incidence of Symptomatic Eustachian Tube Dysfunction Leading to Middle Ear Barotrauma: A Phase 1 Prospective Study. Undersea & Hyperbaric Med: Journal of the Undersea and Hyperbaric Medical Society, Inc. 2019;46(2):95-100. 10. AA B. Diving medicine. American Journal of Respiratory and Critical Care Medicine. 2014;189(12):1479-86. 11. Fitzpatrick DT, Franck BA, Mason KT, SG S. Risk factors for symptomatic otic and sinus barotrauma in a multiplace hyperbaric chamber. Undersea & Hyperbaric Medicine : Journal of the Undersea and Hyperbaric Medical Society, Inc. 1999;26(4):243-7. 12. Goplen FK, Gronning M, Aasen T, SHG N. Vestibular effects of diving -- a 6-year prospective study. . Occup Med 2010;60(1):43-8. 13. Hadanny A., Meir O, Bechor Y., Fishlev G, Bergan J, S E. The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. Undersea & Hyperbaric Medicine: Journal of the Undersea and Hyperbaric Medical Society, Inc. 2016;43(2):113-22. 14. Mozdzanowski C, GA P. Peripheral neuropathy may increase the risk for asymptomatic otic barotrauma during hyperbaric oxygen therapy: Research report. Undersea & Hyperbaric Medicine: Journal of the Undersea and Hyperbaric Medical Society, Inc. 2014;41(4):267-72. 15. RW S. Controlling the rate of middle ear barotrauma: An editorial perspective. Undersea & Hyperbaric Medicine : Journal of the Undersea and Hyperbaric Medical Society, Inc. 2014;41(5):355-6. 16. O'Neill OJ, ED W. The O'Neill grading system for evaluation of the tympanic membrane: A practical approach for clinical hyperbaric patients. Undersea & Hyperbaric Medicine : Journal of the Undersea and Hyperbaric Medical Society, Inc. 2015;42(3):265-71. 17. Mozdzanowski C, GA P. Peripheral Neuropathy May Increase the Risk for Asymptomatic Otic Barotrauma During Hyperbaric Oxygen Therapy: Research Report. Undersea and Hyperbaric Medicine Journal of Undersea and Hyperbaric Medical Society. 2014;41(4):267-72. 18. Nasole E, Zanon V, Marcolin P, G B. Middle Ear Barotrauma During Hyperbaric Oxyeg Therapy; A Review of Occurrences in 5962 Patients. Undersea & Hyperbaric Med: Journal of the Undersea and Hyperbaric Medical Society. 2019;46(2):101-6.

  BACKGROUND

• O'Neill OJ, Dayya D, Varughese L, Marker JA, Perez L, Dayya M. The effect of total compression time and rate (slope) of compression on the incidence of symptomatic Eustachian tube dysfunction and middle ear barotrauma: a Phase II prospective study. Undersea Hyperb Med. 2021 Third Quarter;48(3):209-219.

  PMID: 34390625 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Owen J O'Neill, MD, MPH

  Phelps Hospital Northwell Health

  PRINCIPAL INVESTIGATOR

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 2, 2021
• Study Start: September 8, 2014
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

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)