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American Journal of Otolaryngology - Head and Neck Medicine and Surgery
American Journal of Otolaryngology - Head and Neck Medicine and Surgery
a r t i c l e i n f o a b s t r a c t
Article history: Purpose: Determine whether specific risk factors, symptoms and clinical examination findings are associated with
Received 20 September 2017 hyperbaric oxygen therapy (HBOT) intolerance and subsequent tympanotomy tube placement.
Materials and methods: A retrospective case series with chart review was conducted from 2007 to 2016 of pa-
Keywords: tients undergoing HBOT clearance at a tertiary care university hospital in an urban city. Eighty-one (n = 81) pa-
Eustachian tube dysfunction
tient charts were reviewed for risk factors, symptoms and clinical examination findings related to HBOT
Middle ear barotrauma
eustachian tube dysfunction and middle ear barotrauma. Relative risk was calculated for each variable to deter-
Hyperbaric oxygen therapy
Hyperbaric oxygen intolerance
mine risk for HBOT intolerance and need for tympanotomy tube placement. Risk factor, symptom, physical exam-
Hyperbaric oxygen complications ination and HBOT complication-susceptibility scores were calculated for each patient.
Decongestant therapy Results: Mean risk factor, clinical and HBOT complication-susceptibility scores were significantly higher in pa-
Myringotomy tients who did not tolerate HBOT compared to patients who tolerated HBOT. Patients reporting a history of otitis
Tympanotomy tube placement media, tinnitus, and prior ear surgery were at a higher risk for HBOT intolerance. Patients reporting a history of
pressure intolerance and prior ear surgery were more likely to undergo tympanotomy tube placement. Patients
noted to have otologic findings prior to HBOT were at a higher risk for both HBOT intolerance and tympanotomy
tube placement.
Conclusions: A thorough otolaryngological evaluation can potentially predict and identify patients at risk for
HBOT intolerance and tympanotomy tube placement.
© 2017 Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.amjoto.2017.10.005
0196-0709/© 2017 Elsevier Inc. All rights reserved.
J.E. Cohn et al. / American Journal of Otolaryngology–Head and Neck Medicine and Surgery 39 (2018) 14–19 15
consult. Various classification methods have been used when obstruction or congestion treated with intranasal or oral therapy), ear
conducting an otoscopic examination. The initial TEED classification infections (as an adult or child), hearing loss, vertigo, tinnitus, ear trau-
has been modified over the years, and the other versions of the criteria ma and previous ear surgery (i.e. myringotomy, tympanoplasty with or
are used more commonly [15–16]. The modified TEED classification sys- without mastoidectomy) as well as allergies, social history and family
tem is graded in increasing severity from Grade 0 to 5, with 0 being a history. A comprehensive review of otolaryngological symptoms prior
normal appearing tympanic membrane and 5 being perforation of the to HBOT included aural fullness, otalgia and nasal congestion, among
tympanic membrane [15,17]. The drawback of the TEED criteria is others. The physical examination included a head and neck examina-
inter-observer variability. The O'Neill grading system attempts to re- tion, basic otoscopic examination (non-microscopic), anterior rhinosco-
move inter-observer variability. The O'Neill grading system uses photo- py, and oropharyngeal examination. Specific pertinent physical
graphic images of the tympanic membrane, which allow for more examination findings were noted, including monomeric tympanic
consistent documentation from one examiner to the next. The O'Neill membrane, tympanosclerosis, tympanic membrane retraction and tur-
grading system is graded in increasing severity from Grade 0 to 2. binate hypertrophy. The number of patients for each finding collected
Grade 0 is ETD while Grade 1 and 2 is varying barotrauma [15]. was noted as a frequency and percentage of the total population.
Prospective identification of patients at risk for otic barotrauma has Patients were cleared by our otolaryngology team for HBOT if they
been discussed in the literature. The various physical examination were not having symptoms of ETD during the evaluation. Prior to
methods proposed for identification of barotrauma are otoscopic HBOT, no patients evaluated had symptoms of ETD and were therefore
inspection, ETD evaluation using the Bluestone method, and cleared for therapy. For patients experiencing ETD after the institution
tympanometry [11]. Each of these modalities has its own limitations. of HBOT, our team recommended 2 sprays of intranasal oxymetazoline
Clinical ETD evaluation requires a patient who is awake and coopera- in each nasal cavity prior to their next hyperbaric treatment. When de-
tive. It also is not predictive prior to the patient's first session [6]. Risk congestant therapy was unsuccessful after one session, tympanotomy
factors that have been reported for MEB due to HBOT are age N 60 or tube placement was offered as definitive treatment. All patients requir-
b16, female gender, prior history of ETD, first HBOT session, radiation- ing decongestant therapy and/or tympanotomy tube placement were
related injuries to the head and neck and presence of an artificial airway classified as not tolerating HBOT. Intolerance to HBOT was defined by
[4–5,7,14,18–20]. Unconscious patients and infants are also susceptible a patient experiencing unrelenting otalgia and/or fullness with subjec-
due to a compromised ability to equalize middle ear pressure [11]. Stud- tive hearing loss during or after a hyperbaric session. The session num-
ies have shown that patients with an artificial airway are at a 94% risk ber during which the patients began not to tolerate HBOT was recorded.
for middle ear complications, with 61% receiving tympanotomy tube Each aspect of the patient's history and physical examination was
placement [14]. Allergic rhinitis, nasal congestion, inferior turbinate hy- noted to have or not have each specific finding (Fig. 1). The presence
pertrophy, deviated nasal septum, otitis media and ear pain have also of a particular finding was denoted as a score = 1, and its absence as a
been associated with middle ear barotrauma [21,22]. score = 0 using a standard checklist for each item. A risk factor score
Currently there are no objective criteria which can effectively predict was calculated based upon the sum of having a history of pressure intol-
and identify which patients scheduled to undergo HBOT will have MEB erance, rhinitis, ear infections, tinnitus, hearing loss, vertigo, ear trauma
due to ETD. In addition, there is no consensus on the use of various treat- and ear surgery (possible score range 0–8). A total symptom score was
ment modalities (i.e. topical decongestants, systemic decongestants, calculated based upon the sum of having ear (otalgia or aural fullness)
tympanotomy tubes). Studies have investigated the use of these treat- and sinonasal (nasal congestion) symptoms prior to HBOT (possible
ment modalities after patients have developed intolerance to HBOT. score range 0–3). A total physical examination score was calculated
However, data on the use of these treatments prior to the initiation of based upon the sum of having ear (monomeric tympanic membrane,
HBOT have not been published. The primary goal of this study was to tympanic membrane retraction and tympanosclerosis) and sinonasal
identify patients at risk for developing HBOT intolerance using a thor- (turbinate hypertrophy) examination findings prior to HBOT (possible
ough otolaryngological history and physical examination with emphasis score range 0–4). The risk factor, total symptom and total physical ex-
on sinonasal and otologic processes. amination scores were added together to produce a HBOT complica-
tion-susceptibility score (possible score range 0–15). This novel
2. Materials and methods scoring system was developed by the author (J.C.).
Relative risk was used to determine whether each variable influ-
After institutional review board approval, a retrospective case series enced risk for HBOT intolerance and tympanotomy tube placement. Rel-
with chart review was conducted at our institution. Charts were ative risk was not calculated for a history of vertigo and ear trauma due
reviewed of patients being evaluated by our otolaryngology service for to only one patient having a positive history of each. Independent t-test
HBOT clearance from 2007 through 2016. A multidisciplinary team ap- was used to compare the mean risk factor, symptom, physical examina-
proach to HBOT had been created between the primary wound care tion, and total HBOT complication-susceptibility scores in those who
teams (either vascular surgery or podiatric surgery) and the consultants tolerated and did not tolerate HBOT. Analysis of variance was conducted
needed for HBOT clearance (otolaryngology, ophthalmology and radia- to compare the mean risk factor, symptom, physical examination and
tion oncology). To our knowledge, an otolaryngology consultation was HBOT complication-susceptibility scores of those who tolerated HBOT
not requested for every patient undergoing HBOT. However, of the pa- versus those who improved with oxymetazoline versus those who did
tients who were evaluated by our department, the consultation was not improve with oxymetazoline and required tympanotomy tubes.
completed prior to their first hyperbaric session. In our department, Chi-square test of independence was used to determine the relationship
consultation involved screening patients being considered for HBOT to between each variable and ETD improvement with oxymetazoline. A
assess risk factors, symptoms, and clinical signs of ETD and subsequent multivariate analysis was performed to determine whether age, gender,
MEB. The only exclusion criteria were incomplete consultation in pa- or race influenced risk of HBOT intolerance. The significance level was
tients refusing evaluation, and patients who had tympanotomy tubes set at a P-value (P) less than or equal to 0.05.
at the time of evaluation. After exclusion criteria, a total of eighty-one
(n = 81) patients were identified. 3. Results
Based on the existing literature as well as the clinical experiences of
the otolaryngology staff, a focused history and physical examination Our total study population consisted of eighty-one (n = 81) pa-
was completed for each patient encounter. The patients were asked tients who were evaluated by our department prior to starting HBOT
about their past medical history including a history of pressure intoler- (Table 1). The mean age of our cohort was 59 years. Of the total study
ance (i.e. on an airplane or deep sea diving), rhinitis (i.e. history of nasal population, 55 (67.9%) were male and 50 (61.7%) were African
16 J.E. Cohn et al. / American Journal of Otolaryngology–Head and Neck Medicine and Surgery 39 (2018) 14–19
American. From the total population, 50 (61.7%) patients tolerated requiring tympanotomy tube placement (failed oxymetazoline
HBOT. Seven (8.64%) patients indicated that they had tolerated HBOT therapy). However, this difference was not statistically significant (t-
in the past, of which 5 of 7 (71.4%) tolerated HBOT again during our score = 0.43, P = 0.33) (data not shown).
evaluation period. Those who reported a history of otitis media, tinnitus and prior ear
A total of 31 (38.3%) patients did not tolerate HBOT. Of those 31, 8 surgery were at a higher risk for HBOT intolerance. Those who reported
(25.8%) improved with oxymetazoline, while 23 (74.2%) eventually re- a history of pressure intolerance and prior ear surgery were at a higher
quired tympanotomy tube placement. The average session number at risk for tympanotomy tube placement. Otologic and sinonasal symp-
which patients' intolerance to HBOT developed was 1.80 sessions toms were not significantly associated with HBOT intolerance nor
(range 1–5). The average session number at which patients reported tympanotomy tube placement. Patients noted to have otologic findings
HBOT intolerance for those who improved with oxymetazoline was prior to HBOT were at a higher risk for both HBOT intolerance and
1.62 (range 1–5) sessions, versus 1.87 (range 1–5) sessions for patients tympanotomy tube placement. Patients noted to have turbinate
Fig. 1 (continued).
hypertrophy prior to HBOT were not at a higher risk for HBOT intoler- with oxymetazoline (n = 8), 3 had turbinate hypertrophy on examina-
ance nor tympanostomy tube placement (Table 2). No single variable tion, 2 had a history of tinnitus and hearing loss, 1 had a history of ear
was shown to relate to ETD improvement with oxymetazoline (data infections and vertigo, 1 had aural fullness on examination, 1 had
not shown). nasal congestion on examination, and 1 had monomeric tympanic
Each calculated score was compared between patients who did and membranes on examination. In the multivariate analysis, there was no
did not tolerate HBOT (Table 3). Mean risk factor score was significantly association between age, gender, or race and developing HBOT intoler-
higher in patients who did not tolerate HBOT compared to patients who ance (data not shown).
tolerated HBOT [0.90 vs. 0.50, P = 0.04]. Mean symptom score was not
significantly higher in patients who did not tolerate HBOT compared to 4. Discussion
patients who tolerated HBOT [0.19 vs. 0.12, P = 0.23]. Mean physical ex-
amination score was significantly higher in patients who did not toler- Although there are systems in place for identifying patients with ETD
ate HBOT compared to patients who tolerated HBOT [0.48 vs. 0.22, P and MEB after undergoing HBOT sessions, no effort has been made pre-
= 0.03]. Mean HBOT complication-susceptibility score was significantly viously to clearly and systematically identify those at risk prior to HBOT.
higher in patients who did not tolerate HBOT compared to patients who In our study, we approached the evaluation of HBOT patients in a multi-
tolerated HBOT [1.58 vs. 0.84, P = 0.02]. dimensional manner which included a thorough otolaryngological his-
Furthermore, these scores were compared between those who toler- tory, review of systems and physical examination. Additionally, we ad-
ated HBOT, improved with oxymetazoline and those who did not im- dressed HBOT intolerance both with medical and surgical treatment.
prove with oxymetazoline and required tympanotomy tubes. Between A thorough history was determined to be an important evalua-
these three groups, there were no significant differences in risk factor, tion tool. Those who reported a history of otitis media (n = 4), tinni-
symptom, physical examination and HBOT complication-susceptibility tus (n = 8) and/or prior ear surgery (n = 2) were at a higher risk for
score (data not shown). However, among the patients who did improve HBOT intolerance. Patients who had a history of pressure intolerance
18 J.E. Cohn et al. / American Journal of Otolaryngology–Head and Neck Medicine and Surgery 39 (2018) 14–19
Table 1 Table 3
Baseline characteristics of patient cohort (N = 81). Score results: HBOT intolerance vs. Tolerance.
Characteristics Frequency (%) Score type Score, mean ± SDa t-Score P value
Table 2
Relative risks of factors associated with HBOT intolerance and tympanotomy tube placement.
Abbreviations: HBOT, hyperbaric oxygen therapy; 95% CI, 95% confidence interval.
a
Statistically significant risk in developing HBOT (P value ≤ 0.05).
b
Statistically significant risk in requiring tympanotomy tube placement (P value ≤ 0.05).
J.E. Cohn et al. / American Journal of Otolaryngology–Head and Neck Medicine and Surgery 39 (2018) 14–19 19
turbinate hypertrophy), this was not shown to be significantly true in and delays in therapy for these patients. Additionally, the utilization of a
our study. pre-treatment scoring system taking into account these risk factors,
The majority (74.2%) of patients who did not tolerate HBOT symptoms and physical examination findings can potentially help to
eventually required tympanotomy tube placement. Out of the total pa- predict those at risk for HBOT intolerance and to offer them treatment
tients (n = 23) who ultimately underwent tympanotomy tube place- prophylactically. The results of the study should serve as a supplement
ment for HBOT intolerance, 21 (91.3%) had resolution of their to, rather than a replacement of, established systems such as the TEED
symptoms (otalgia or fullness with hearing loss). The remaining 2 pa- classification and O'Neill grading system. However, our findings indicate
tients (8.7%) did not improve due to otorrhea. This is not unusual that further research should be encouraged.
given that 5–49% of patients experience early post-tympanotomy tube
otorrhea, which occurs b 2 weeks postoperatively [23]. However, no dis-
Conflicts of interest
tinction is made between the pediatric and adult population.
We developed a scoring system to assist providers in risk-stratifying
None.
patients about to undergo HBOT. Patients with higher mean risk factor,
physical examination and HBOT complication-susceptibility scores are
susceptible to HBOT intolerance. However, they do not have significant- Funding statement
ly higher symptom scores. When comparing these scores between pa-
tients who tolerated HBOT, improved with oxymetazoline and those This research did not receive any specific grant from funding agen-
requiring tympanotomy tubes there was no statistical significance. cies in the public, commercial, or not-for-profit sectors.
Therefore, it can be concluded that our scoring may assist providers in
predicting who will not tolerate HBOT and need prophylactic
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