Study On The Sensitivity And Specificity Of Eustachian Tube Functional Assessment Methods

The eustachian tube（ET）is the lumen that connects the middle ear cavity to the nasopharynx,with cartilage on the medial two-thirds and bone on the lateral third.ET has three functions of regulating the gas pressure equilibrium in the middle ear cavity,preventing the nasopharyngeal secretions,bacteria and viruses from flowing into the middle ear,and preventing endogenous noise from damaging the middle ear and inner ear.The middle ear pressure balance can be adjusted through the opening and closing of the eustachian tube.Normal ET ventilation function is crucial to stabilize the middle ear environment.Eustachian tube dysfunction（ETD）can lead to secretory otitis media,atelectasis of the middle ear,cholesteatoma of the middle ear and other middle ear diseases.Therefore,it is very important to establish an effective and practical ventilation function examination method to assess the function of eustachian tube.At present,there are many kinds of examination methods in clinical practice,but each has its own emphasis,there is still a lack of examination method to assess eustachian tube function comprehensively.PartⅠ:Comparison of Sonotubometry,Impedance,Tubo-tympano-aerography,and Tubomanometry to Test Eustachian Tube Function of Healthy SubjectsObjectives:To provide an objective basis for the clinical diagnosis of ET function,we explored the characteristics of sonotubometry,impedance,tubo-tympano-aerography（TTAG）,and tubomanometry（TMM）in volunteers with healthy ETs,and compare them with each other.Methods:Sonotubometry,impedance,TTAG,and TMM tests were performed in 110 healthy ears of 55 volunteers,the ET-opening rate of foure tests were compared each other,and the characteristics of each ET test were compared and discussed.Results:The ET-opening rates of sonotubometry with dry swallowing,impedance with Valsalva maneuver,TTAG with Valsalva maneuver and TMM at50 mbar were 90.90%,92.70%,90.00%and 94.50%,respectively,there were no significant difference in ET-opening rate between the four tests.The ET-opening rate of sonotubometry with dry swallowing maneuver was significantly higher than swallowing with water（P=0.000）,but there was no significant difference between it and the ET-opening rate of sonotubometry with Valsalva maneuver（P=1.000）.When TMM at 20,30,40,50 mbar,the ET-opening rates were 64.5%（71 ears）,80.0%（88 ears）,90.9%（100 ears）,94.5%（104 ears）,and the pressure of external auditory canal were 0.630±0.578,0.857±0.608,1.046±0.566,and1.225±0.537 dapa,respectively,both the ET-opening rate and the external auditory pressure increased with the increase of nasopharyngeal pressure（r₁=0.271,p₁=0.000;r₂=0.315,P₂=0.000）.There was negative correlation between the size of ETS-7 and the R value distribution 0f TMM at 30,40,50 mbar（P=0.000）.Conclusions:The four ET function tests of sonotubometry,impedance,TTAG and TMM were used to evaluate ET function,each test with its advantages and disadvantages.Sonotubometry with ability of detecting the active ET open function,impedance and TTAG were used to detect the passive ET open function,TMM was used to detect both the passive and active ET open function.In clinical practice,suitable function test of eustachian tube should be selected according to the specific situation of patients.PartⅡ:Discussion on the Diagnostic Strategy of Eustachian Tube Function in Secretory Otitis Media,Patulous Eustachian Tube,and Middle Ear Atelectasis with Habitual SniffingObjectives:To provide a reliable,accurate and effective feasible scheme for diagnosing different types of ETD,ETDQ-7,sonotubometry,impedance,TTAG,TMM and ETS-7 were used to analyze the ET function of different types of ETD,their diagnostic characteristics were discussed,and diagnostic value of various eustachian tube functional assessment methods were evaluated.Methods:Different types of ETD that include of obstructive ETD（secretory otitis media,60 ears）,patulous ET（25 ears）and ET close insufficiency（middle ear atelectasis with habitual sniffing,23 ears）were assessed by ETDQ-7,sonotubometry,impedance,TTAG,TMM and ETS-7,the characteristics of each eustachian tube functional assessment method in the diagnosis of different types of ETD were analyzed,and the sensitivity and specificity of eustachian tube functional assessment methods in the independent and combined diagnosis were compared.Results:The mean ETDQ-7 of the normal control group,the obstructive ETD group,the abnormal ET dilatation group and the ET close insufficiency group,were 8.15±1.31,22.30±7.94,20.24±9.06,and 20.96±6.34,respectively.The ETDQ-7 of the three ETD groups was significantly higher than that of the normal control group（P=0.000）,but there was no significant difference in the ETDQ-7 of the three ETD groups（P=1.000）.In sonotubometry with dry swallowing,the ET-opening rates of the control group,the obstructive ETD group,the patulous ET group and the ET close insufficiency group were 90.90%,25.00%,92.00%and 52.20%,respectively,there was no significant statistical difference in ET-opening rate between patulous ET group and the control group,but they were significantly higher than that of the obstructive ETD group and the ET closed failure group.In the impedance with Valsalva maneuver test,the ET-opening rates of the normal control group,the patulous ET group and the ET close insufficiency group were 92.70%,96.00%and 73.90%,respectively,and there were no significant difference in the three groups,but their opening rates were higher than the 23.30%of obstructive ETD group and it was statistically significant.Both the ET-opening rate of patulous ET group and ET close insufficiency group were detected by TTAG with sniffing maneuver were 100%,which was higher than the normal control group（31.80%）and obstructive ETD group（50.00%）,and there was statistical significance.The ET-opening rate of patulous ET were detected by TTAG with deep breath maneuver was 100%,while it was 0 in the other three groups.In the TMM test,there was no statistical difference in the ET-opening rate of the control group,the patulous ET group and the ET closed failure group,but it was significantly higher than the obstructive ETD group.The mean ETS-7of the control group,the obstructive ETD group,the ET abnormal dilatation group,and the ET closed barrier group.were 11.61±2.57,5.10±2.82,13.40±1.04,and10.00±3.05,respectively,and there were significant differences between each other.In the diagnosis of overall ETD,the Youden index and Kappa consistency of ETDQ-7 diagnosis were higher than other single test methods.For the diagnosis of obstructive ETD group,the diagnostic sensitivity,specificity,Youden index and Kappa consistency of the assessment methods such as ETS-7,impedance with Valsalva maneuver and sonotubometry in parallel were 0.983,0.766,0.749 and 0.632,respectively,which in parallel with ETDQ-7,and the Kappa consistency was up to 0.717.Both the diagnostic sensitivity and specificity of the patulous ET group by TTAG with deep breathing maneuver were 1.0.The diagnostic sensitivity,specificity,Youden index and Kappa consistency of ET close insufficiency group by TTAG with sniffing maneuver in series endoscopic examination were 1.0,0.938,0.938 and 0.763,respectively.Conclusions:Different types of ET functional assessment methods have their own characteristics.ETDQ-7 is suitable for preliminary screening of overall ETD;sonotubometry,impedance with Valsalva maneuver,TMM,ETS-7 are useful for the diagnosis of obstructive ETD at some extend,TTAG with deep breathing is suitable for the diagnosis of patulous ET,TTAG-sniffing in combination with endoscopy is suitable for the diagnosis of ET close insufficiency.The combined application of ET functional assessment methods was helpful to improve the accuracy of ETD diagnosis,but the corresponding assessment methods should be selected according to the type of eustachian tube dysfunction for diagnosis.PartⅢ:Development and Preliminary Application of Sonotubometry under nasopharyngeal pressureObjectives:This study developed a novel test for ET function that is sonotubometry with nasopharyngeal pressure,which is standard pressure is implemented in nasopharynx synchronously when taking the sonotubometry test.This study introduces the principle and operation of sound pressure method for the first time,and discuss its characteristics and feasibility of testing ET function,so as to provide an accurate and effective test method for the diagnosis of ET function.Methods:The equipment of sonotubometry with nasopharyngeal pressure was composed of eustachian tube function synthesizer and tubomanometer.Subjects to sitting,a small amount of water was held in the mouth,the speaker of sonotubometry was fitted to one nostril to generate a 7-k Hz narrowband noise,the maximum output was 123 d B,and a microphone was sealed into the same external ear canal to detect sound pressure by using a baseline of 50 d B that had already been calibrated;a single-pronged nasal applicator fitted to the other nostrils to generate standard nasopharyngeal pressures（30,40,and 50 mbar）.After swallowing water,both the sound pressure and nasopharyngeal pressure of the external auditory canal were recorded,and ET-opening was defined with the sound pressure of the external auditory canal≥5d B as the critical value.Non-parametric Cochran Q test was used to compare the three ET functional tests to detect the normal ET-opening rate,and ICC（intra-group correlation coefficient）was used to evaluate the feasibility of repeated measurement of sound pressure method.The ET-opening rate of the normal control group and the secretory otitis media group were compared by chi-square test,and the sound pressure of two groups were compared by non-parametric test.Results:In the healthy control group,the ET-opening rates detected by sonotubometry with nasopharyngeal pressure 30,40 and 50 mbar were 93.40%,98.10%and 98.10%,respectively,which were higher than those detected by sonotubometry（80.20%）and TMM with 30,40 and 50 mbar（74.50%,86.80%and 90.60%）.The R value decreased with the increase of nasopharyngeal pressure（R=-0.298,p=0.000）,and the sound pressure increased with the increase of nasopharyngeal pressure（R=0.251,p=0.000）.In the secretory otitis media group,the ET-opening rates detected by sonotubometry with nasopharyngeal pressure of30,40 and 50 mbar were 63.80%,72.30%and 83.00%,respectively,which were significantly higher than that in TMM with corresponding nasopharyngeal pressure of TMM（30,40 and 50 mbar）were 36.20%,53.20%and 57.40%,respectively（P<0.05）.The median sound pressure of secretory otitis media group at 30,40,50 mbar nasopharyngeal pressure was 10,11.5,14 d B,significantly lower than that of the normal control group.Similarly,the ET-opening rates of the secretory otitis media group in every nasopharyngeal pressure were significantly lower than that of the control group（P<0.05）.Conclusions:Sonotubometry with nasopharyngeal pressure is an appropriate hybrid eustachian tube functional assessment method,which has the ability to test both active and passive ET-opening function,and with a high sensitivity to detect ET-opening,which can be used to quantificat ET function.Sonotubometry with nasopharyngeal pressure is a very promising method for the evaluation of ET function,which has a good clinical application.However,the critical value for the diagnosis of ETD has not been determined in the preliminary study stage,and further study is still needed.