Eustachian Tube DysfunctionNCT04776967
Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II Prospective Study.
A study testing Hyperbaric Compression Profile in people with Eustachian Tube Dysfunction and Middle Ear Barotrauma, run by Northwell Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eustachian Tube Dysfunction, Middle Ear Barotrauma, Middle Ear Disease
- What is being tested?
- Hyperbaric Compression Profile
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2014to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Any patient meeting the indications for hyperbaric oxygen treatment.
-
Exclusion Criteria: Any patient with absolute contraindications to hyperbaric oxygen treatment, chronic bilateral perforation of the tympanic membrane or prior bilateral myringotomy tube placement.
-
Trial locations and contacts
1 site in 1 country.
United States1 site
Phelps Hospital Northwell Health
Sleepy Hollow, New York, 10591
About this study
Official title: The Effect of Total Compression Time and Rate (Slope) of Compression on Incidence of Symptomatic Eustachian Tube Dysfunction and Middle Ear Barotrauma: 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 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.
Read the detailed description
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The investigators 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 rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation as a group, rather than for each individual patient.
Data will be collected prospectively on group patient-treatment exposures. The investigators will randomly assign patient-treatment group exposures to four different time interval and rate (slope) of compression. All patients, within every patient-treatment group exposure, received all 4 compression profiles (CP) on a rotating basis, in effect having patients serve as their own controls in a crossover design and to reduce the risk of treatment order on the effects observed. These compression rates and slopes were identical to those used in the Phase I trial. All patients experiencing symptoms of MEB requiring compression stops will be evaluated post-treatment for the presence of ETD and MEB using the O'Neill Grading System (OGS) for ETD/MEB.
For approximately 10 years, the investigators hyperbaric center used a routine daily multiplace chamber treatment protocol to a depth of 45 feet of seawater (fsw) (modified U.S. Navy Treatment Table 9). The chamber was compressed over a 10-minute time interval representing a 4.5 fsw/minute uniform rate of compression. This 4.5-fsw/minute linear rate (slope) of compression rate was maintained throughout the total 10-minute time interval of treatment and will be used as a baseline compression rate to compare all other compression schedules [total compression time interval/compression rates (slopes)]. The investigators will prospectively collect data on patient-treatment group exposures after formalizing four different compression schedules each including a unique combination of compression rate (slope) and time intervals of compression. This was similar to the Phase I study.
Data will be collected prospectively on all patients recruited and receiving treatment from February 11, 2019, and February 10, 2020, and combined with the data obtained in our Phase I trial collected from September 8, 2014 to September 8, 2016. This Phase II study defines the unit of observations as a multiplace patient-treatment group exposure rather than individual patient treatment exposures. This approach was considered appropriate as a treatment stop or hold in a multiplace chamber affects all other patient occupants in the same treatment group exposure.
To mitigate the risk of confounding, only the first stop will be used as the stop or hold indicator for that particular patient-treatment group exposure. Data will be collected on the patient(s) experiencing the stop or hold. All patients will undergo pre-treatment video otoscopy with baseline tympanic membrane (TM) photos and video of TM motion documenting the patients ability to equalize. This is used to assess potential Eustachian tube patency and proper equalization performance to help exclude individual patient technique as a confounding variable. Photos will be repeated at the end of treatment on any patient(s) complaining of symptoms referable to ETD/MEB that require a stop during compression.
Multiple stops for the same patient on the same treatment will not be considered. Only the first compression stop or hold during each treatment exposure will be recorded or assigned as a patient-treatment stop representing that particular patient-treatment group exposure. Compression stops will be made when any patient experiences difficulty equalizing (requests a stop or complains of ear discomfort of any type).
Repeat video otoscopy will be conducted on all patients complaining of symptoms referable to ETD or MEB to objectively document the grade of barotrauma at the end of the treatment. The OGS system will be used to record the severity of the ETD or MEB. The depth of the stop, the treatment number for that particular patient, and the actions taken to alleviate the symptoms during equalization will be recorded.
The depth of the compression stop will be recorded in feet of seawater (fsw) as will be the ascent (fsw) required for the patient to clear the middle ear pressure and relieve the symptoms. The patients symptoms must be resolved, rendering the patient asymptomatic and able to continue the treatment compression profile. All team members (physicians, nurses, and technicians) present and working on the day of the exposure, are responsible for viewing the patients pre and post tympanic membrane photos and determining the grade of barotrauma using the OGS criteria.
All stops were categorized under the respective compression protocol used for that particular patient-treatment group exposure. Data will then compared using both descriptive and inferential statistical analysis including the risk difference, odds ratio (OR), two-tailed Chi Square analysis using α=0.05, and outcomes will be studied separately in a logistic regression analysis.
- Conditions
- Eustachian Tube Dysfunction, Middle Ear Barotrauma, Middle Ear Disease, Middle Ear; Injury, Pressure Injury, Ear Barotrauma
- Being tested
- Hyperbaric Compression Profile
- Keywords
- Ear Pressure, Otic Barotrauma, Hyperbaric, Pressure Equalization, O'Neill Grading System, Compression Rate
- Medical subject headings
- Wounds and Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Compression ProfileProcedure or surgery
Also called Hyperbaric Compression Schedule
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Hyperbaric Compression Profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- = Objective evidence of increased erythema, air trapping or serous/serosanguinous effusion
- = Any frank bleeding in the middle ear space, tympanic membrane or external ear canal or perforation
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start8 Sep 2014
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Owen J O'Neill, MD, MPH, Northwell Health
- Investigators
- Owen J O'Neill, MD, MPH, Principal investigator, Phelps Hospital Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776967
- Sponsor's protocol ID
- Compression Hyperbaric II
- Status last verified
- Aug 2021
- First submitted
- 10 Feb 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Would consider if other researchers are studying similar research question and interested in collaboration.
Publications
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.
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.
PubMed 34390625
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Total Compression Time and Rate (Slope) of Compression on Incidence of Symptomatic Eustachian Tube Dysfunction and Middle Ear Barotrauma: A Phase II Prospective Study.
- ClinicalTrials.gov ID
- NCT04776967
- Acronym / sponsor ID
- Compression Hyperbaric II
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 8 Sep 2014 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The investigators 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 rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation as a group, rather than for each individual patient.
Data will be collected prospectively on group patient-treatment exposures. The investigators will randomly assign patient-treatment group exposures to four different time interval and rate (slope) of compression. All patients, within every patient-treatment group exposure, received all 4 compression profiles (CP) on a rotating basis, in effect having patients serve as their own controls in a crossover design and to reduce the risk of treatment order on the effects observed. These compression rates and slopes were identical to those used in the Phase I trial. All patients experiencing symptoms of MEB requiring compression stops will be evaluated post-treatment for the presence of ETD and MEB using the O'Neill Grading System (OGS) for ETD/MEB.
For approximately 10 years, the investigators hyperbaric center used a routine daily multiplace chamber treatment protocol to a depth of 45 feet of seawater (fsw) (modified U.S. Navy Treatment Table 9). The chamber was compressed over a 10-minute time interval representing a 4.5 fsw/minute uniform rate of compression. This 4.5-fsw/minute linear rate (slope) of compression rate was maintained throughout the total 10-minute time interval of treatment and will be used as a baseline compression rate to compare all other compression schedules [total compression time interval/compression rates (slopes)]. The investigators will prospectively collect data on patient-treatment group exposures after formalizing four different compression schedules each including a unique combination of compression rate (slope) and time intervals of compression. This was similar to the Phase I study.
Data will be collected prospectively on all patients recruited and receiving treatment from February 11, 2019, and February 10, 2020, and combined with the data obtained in our Phase I trial collected from September 8, 2014 to September 8, 2016. This Phase II study defines the unit of observations as a multiplace patient-treatment group exposure rather than individual patient treatment exposures. This approach was considered appropriate as a treatment stop or hold in a multiplace chamber affects all other patient occupants in the same treatment group exposure.
To mitigate the risk of confounding, only the first stop will be used as the stop or hold indicator for that particular patient-treatment group exposure. Data will be collected on the patient(s) experiencing the stop or hold. All patients will undergo pre-treatment video otoscopy with baseline tympanic membrane (TM) photos and video of TM motion documenting the patients ability to equalize. This is used to assess potential Eustachian tube patency and proper equalization performance to help exclude individual patient technique as a confounding variable. Photos will be repeated at the end of treatment on any patient(s) complaining of symptoms referable to ETD/MEB that require a stop during compression.
Multiple stops for the same patient on the same treatment will not be considered. Only the first compression stop or hold during each treatment exposure will be recorded or assigned as a patient-treatment stop representing that particular patient-treatment group exposure. Compression stops will be made when any patient experiences difficulty equalizing (requests a stop or complains of ear discomfort of any type).
Repeat video otoscopy will be conducted on all patients complaining of symptoms referable to ETD or MEB to objectively document the grade of barotrauma at the end of the treatment. The OGS system will be used to record the severity of the ETD or MEB. The depth of the stop, the treatment number for that particular patient, and the actions taken to alleviate the symptoms during equalization will be recorded.
The depth of the compression stop will be recorded in feet of seawater (fsw) as will be the ascent (fsw) required for the patient to clear the middle ear pressure and relieve the symptoms. The patients symptoms must be resolved, rendering the patient asymptomatic and able to continue the treatment compression profile. All team members (physicians, nurses, and technicians) present and working on the day of the exposure, are responsible for viewing the patients pre and post tympanic membrane photos and determining the grade of barotrauma using the OGS criteria.
All stops were categorized under the respective compression protocol used for that particular patient-treatment group exposure. Data will then compared using both descriptive and inferential statistical analysis including the risk difference, odds ratio (OR), two-tailed Chi Square analysis using α=0.05, and outcomes will be studied separately in a logistic regression analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Compression Profile 4 | Active comparator | Procedure: Hyperbaric Compression ProfileCompression 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 |
| Compression Profile 3 | Active comparator | Procedure: Hyperbaric Compression ProfileCompression 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 |
| Compression Profile 2 | Active comparator | Procedure: Hyperbaric Compression ProfileCompression 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 |
| Compression Profile 1 | Active comparator | Procedure: Hyperbaric Compression ProfileCompression 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Compression ProfileAlso: Hyperbaric Compression ScheduleA 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. | Procedure or surgery | Compression Profile 1, Compression Profile 2, Compression Profile 3, Compression Profile 4 |
Primary outcome
Compression stops or holds during the compression phase of hyperbaric oxygen treatments
Time frame: 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
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.
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
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Background1. 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.
- Derived from this study: PubMed 34390625O'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.
- Individual participant dataSharing planned: Yes. Would consider if other researchers are studying similar research question and interested in collaboration.
Related trials for Eustachian Tube Dysfunction
Recruiting
Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
Patulous Eustachian Tube Dysfunction, Eustachian Tube Dysfunction
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Not yet recruiting
Active vs. Passive VR During Office-based ENT Procedures
Pain, Anxiety
RecruitingObservational study
AERA Pediatrics Registry
Dysfunction of Eustachian Tube
Enrolling by invitationObservational study
Diagnostic Precision and Accuracy Using the Teed Scoring System Versus the O'Neill Grading System
Otic Barotrauma, Pressure Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Owen J O'Neill, MD, MPH principal investigator
Phelps Hospital Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Compression Profile in people with Eustachian Tube Dysfunction and Middle Ear Barotrauma, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compression stops or holds during the compression phase of hyperbaric oxygen treatments (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04776967, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.