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Evaluation of middle ear function in cleft palate patients MINISTRY OF EDUCATION AND TRAINING MINISTRY OF HEATH HANOI MEDICAL UNIVERSITY ====== KHIEU HUU THANH EVALUATION OF MIDDLE EAR FUNCTION IN CLE[.]
MINISTRY OF EDUCATION AND TRAINING MINISTRY OF HEATH HANOI MEDICAL UNIVERSITY ====== KHIEU HUU THANH EVALUATION OF MIDDLE EAR FUNCTION IN CLEFT PALATE PATIENT Specialism : Otorhinolaryngology Code : 9720155 ABSTRACT OF THESIS HA NOI - 2022 The thesis has been completed at HANOI MEDICAL UNIVERSITY Supervisors: Supervisor 1: Assoc Prof Luong Thi Minh Huong, PhD Supervisor 2: Nguyen Dinh Phuc, PhD Reviewer 1: Reviewer 2: Reviewer 3: The thesis will be present in front of board of university examiner and reviewer lever at…:… on …/…/2022 This thesis can be found at: National Library: National Medical Informatics Library Library of Hanoi Medical University THE LIST OF WORKS HAS PUBLISHED AND RELATED TO THE THESIS Khieu Huu Thanh, Nguyen Dinh Phuc, Dao Trung Dung, Nguyen Thanh Thai, Luong Thi Minh Huong (2019), The initial results of ventilation tube insert on 1st time palatoplasty patients suffering from otitis media with effusion, Journal of Practical Medicine, No 5(1099) 2019, p 20-30 Khieu Huu Thanh, Luong Thi Minh Huong (2019), Evaluating the function of eustachian tube in cleft palate patients with otitis media with effusion before and after palatoplasty, Vietnam Medical Journal, Vol 481, No 2, August 2019, p 173-177 Khieu Huu Thanh, Nguyen Dinh Phuc, Luong Thi Minh Huong (2019), The tympanogram characteritics of cleft palate patients suffering from otitis media with effusion, Vietnam Journal of Science and Technology, Vol 61, No 12, December 2019, p 1-4 Khieu Huu Thanh, Nguyen Dinh Phuc, Luong Thi Minh Huong (2020) The middle ear disease after ventilation tube insertion on the palatoplasty patients, Vietnam Journal of Otorhinolaryngology – Head and Neck Surgery, Vol (65-50) No December 2020, p 22-28 INTRODUCTION Chronic eustachian tube dysfunction due to abnormalities in levator veli palatini and tensor veli palatini along with palate deficiency increases the incidence of middle ear diseases in cleft palate (CP) children up to 94%, mostly is otitis media with effusion (OME) The prolonged inflammatory process affects hearing during the "golden period" of children's language development, causing difficulties in communication and learning Middle ear disease management is part of the multidisciplinary treatment in cleft palate patients, which has been applied around the world Because of the subtle clinical manifestations, it is necessary to combine endoscopy and evaluation of middle ear function by audiometry and tympanometry to diagnose and follow-up middle ear disease in cleft palate children The tympanic ventilation tube acts as an artificial eustachian tube, which amelorates ventilation, mucus drainage, improves hearing function and limits complications due to eustachian tube dysfunction Studies show that the rate of otitis media in cleft palate children was as high as 85.7% after internal medicine treatment or palatoplasty Therefore, ventilation tubes insertion (VTI) is recommended by the American Speech-Language-Hearing Association to be performed early in cleft palate children with otitis media Conducting research on the characteristics of middle ear desease in cleft palate children and performing ventilation tubes insertion to improve the quality of treatment are essential and empirical In Vietnam, this topic has not been paid enough attention, with few the studies and short follow-up time Therefore, we researched the topic: "Evaluation of middle ear function in cleft palate patients" with two aims: Evaluation of middle ear function in cleft palate patients by endoscopic, audiometry and tympanometry Evaluation of middle ear function improvement after ventilation tube insertion and palatoplasty SCIENTIFIC AND PRACTICAL MEANINGS There is a high rate of middle ear disease in cleft palate children We investigated the relationship between endoscopic and middle ear function to help diagnose and monitor middle ear status in cleft palate children To treat otitis media in cleft palate children, we applied a combination of ventilation tube insertion and palatoplasty and obtained positive results The intervention, therefore, is recommended to cleft palate children The intervention coordination between Otolaryngology and Maxillofacial Surgery, Plastic Surgery in monitoring and treating middle ear disease in cleft palate patients NEW CONTRIBUTIONS OF THE DISSERTATION Describe the characteristics of middle ear disease by endoscopic examination, middle ear function by tympanometry and audiometry of cleft palate patients with palatoplasty Determining the relationship between endoscopic ear characteristics and middle ear function by tympanometry, audiometry in cleft palate patients The application has the results of ventilation tube insertion in combination with palatoplasty on cleft palate patients suffer from otitis media STRUCTURE OF THE DISSERTATION The thesis consists of 125 pages excluding appendices of pictures, research records, list of patients and 205 references, of which: pages of introdution and research aims, 36 pages of overview, 22 pages of patients and methods, 28 pages of results, 34 pages of discussion, pages of conclusions and page of recommendations CHAPTER LITERATURE OVERVIEW 1.1 Background 1.1.1 Outside Vietnam In 1897, Alt described the association CP with hearing loss and causing middle ear diseases In 1969, Paradise et al showed that middle ear disease was present in the first month of life in all CP infants In 1981, Moller found that in CP children with pure tone average (PTA) less than 20dB, middle ear pressure decreased more than -150mmH2O, type B tympanogram was found in 85% of children with OME In 2003, Zheng performed VTI and palatoplasty for 39 OME in CP children, 48.7% ears improved, hearing increased 17dB after months 1.1.2 In Vietnam In 1998, Nguyen Thi Hoai An saw the OME rate up to 76.4% In 2013, Nguyen Dinh Truong found that after months of VTI in 50 children with CP±L, 60% of the ears had tympanic membrane (TP) back to normal In 2019, according to Khieu Huu Thanh et al., the rate of OME after palatoplasty without VTI for months remained as high as 85.7% 1.2 Evaluation of middle ear function by tympanometry and audiometry 1.2.1 Tympanometry As a simple, fast, objective measurement method based on middle ear impedance according to pressure changes, it can be performed in children with CP Eustachian tube dysfunction leads to altered tympanogram in CP patients According to Zingade (2009), there are 64.77% of type B, 29.54% type A The disadvantage of tympanometry is that it cannot assess directly dysfunction of the eustachian tube, and cannot evaluate the function of the tube when the eardrum is perforated 1.2.2 Pure Tone Audiometry Pure tone audiometric is a subjective audiometric method based on the patient's response to acoustic stimuli In adults and children can cooperate, they will respond to acoustic stimuli by pressing a button or raising a hand In young children aged about 30-48 months, the measure is based on reinforcement of conditional sound responses when the child plays games This technique is called conditioned play audiometry (CPA) From about - years old, measurement by ear finger or button press can be trusted In CP patients with OME or acute otitis media (AOM), the audiogram shows a mild conductive hearing loss pattern In patients with TP atelectasis, grade I: near-normal audiogram, grade II: mild conductive hearing loss, grade III: audiogram with conductive hearing loss above 40 dB, grade IV: Audiogram showing mixed hearing loss 1.3 Middle ear disease in cleft palate patient 1.3.1 Pathogenesis of middle ear disease in cleft palate patients Dysfuntion of muscles associated with the eustachian tube: Children with CP were lack of insertion of the tensor veli palatini and levator veli palatini into the palatine aponeurosis The tensor veli palatini was lack of insertion to the tubal cartilage, fewer tendons and muscle fibers, and the levator veli palatini was hypoplastic As a result, muscle tone decreases, the ability to open the eustachian tube is affected The eustachian tube is also increased floppiness and easier collapsibility Eustachian tube dysfunction: Muscles dysfuntion cause tubal dysfunction, leading to functional tubal occlusion in CP children In addition, mechanical occlusion may be caused by edema secondary to infection or by adenoid Consequences of eustachian tube dysfunction: The decline in eustachian tube function causes poor gas exchange, unable to equalize pressure between the tympanic cavity and the outside The negative pressure in the tympanic cavity assumed to suck a transudate from the blood vessels, lead to changes the appearance of mucus, the increased of secrectory cells and submucosa glands This, in turns, obstruct the eustachian tube, which inhibits the drainage of fluid from the tympanic cavity to the nasopharynx, and sucks nasopharyngeal fluid and bacteria into the middle ear This vicious pathological cycle leads to chronic changes in the middle ear mucosa, in the eardrum, and inhibition of mastoid pneumatization Prolonged blockage of the tube causes effusion in the middle ear The chronic inflammatory reaction destroys the fiber layer of eardrum, causes atelectasis and retraction pocket, which reduces the air space in the tympanic cavity and ventilation, and worsen negative pressure 1.3.2 Characteristics of middle ear diseases in cleft palate patients Diagram 1.2 Outcomes of eustachian tube dysfunction (Source: Nguyen Tan Phong) In CP patients, chronic tubal dysfunction leads to middle ear diseases of different degree, which are mainly manifestations of otitis media with closed TP, namely: OME (serous otitis media, mucoid otitis media and mucopurulent otitis media), atelectasis, pocket retraction Nevertheless, the literature has been demonstrated the assoiciation between these types of middle ear disease with the possible transformation from one type to another For instance, we may observe myringosclerosis, chronic otitis media (CSOM) in patients 1.4 1.4.1 Treatment of middle ear disease in cleft palate patients Tympanic ventilation tube insertion 1.4.1.1 Indications for ventilation tube insertion in CP patients According to the American Academy of Otolaryngology - Head and Neck Surgery, CP children have a higher rate of OME, hearing loss, and language delay than normal children, so early intervention is necessary for these patients In Vietnam, according to the technical process of medical examination and treatment, in Otolaryngology by the Ministry of Health in 2012, there are no specific guidelines on VTI for each disease, and for such high-risk popolations as CP children in particular 1.4.1.2 Outcomes and complications Results: According to the authors in the world, placing VTI can immediately overcome the loss of hearing and fluid in OME, and prevent the chronic progression of the disease According to Rosenfeld (2004), the rate of TP returning to normal after VTI was 62%, PTA increased from 6-12 dB after VTI placement Complications: Ear otorrhea was the most common subgroup with the rate from 3.4% to 96.9% The tube blockage rate was 9.5% Ventialtion tube (VT) blockage or early VT extrusion leads to recurrent OME or AOM VT was extruded before months with a ratio of 20/35 ears 1.4.2 The role of palatoplasty In the short term, there is little evidence that palatoplasty resolves tubal dysfunction or OME According to pilot study, the rate of OME months before and after palatoplasty (no VTI) was 91.9% and 85.7%, respectively CHAPTER PATIENTS AND METHODS 2.1 Patients A samples of 106 patients with secondary CP who are children under 16 years of age with middle ear disease underwent palatoplasty surgery Among them 183 ears were performed VTI surgery at Vietnam - Cuba Friendship Hospital, Hanoi from January 2016 to December 2019 2.1.1 Selection criteria • Patients with secondary cleft palate, possibly with cleft lip • Had endoscopic examination, tympanometry, possibly accompanied by audiometry • Performed palatoplasty • Had tympanic ventilation tube insertion • Be followed up for at least 12 months • Guardian consented to participate in the study 2.1.2 Exclusion criteria CP patients in the syndromes, have other congenital malformations causing deformities of maxillofacial regions Patients dropped out of treatment or were not followed up adequately 2.2 Methods 2.2.1 Design A prospective, descriptive study of case series with clinical intervention, without a control group 2.2.2 Number of patients studied In the study, the selective sampling method was chosen Objective 1: 106 children with secondary CP were indicated for palatoplasty, endoscopic examination, tympanometry, possibly accompanied by audiometry Objective 2: 183 ears diagnosed with OME, recurrent AOM, grade IIIII atelectasis, has performed palatoplasty combined with VTI (77 children performed ears, 29 children performed ear) 10 o Retained VT: OME, AOM, atelectasis, secrectory, noninflammatory o Extruded VT: OME, AOM, atelectasis, perforate, noninflammatory o Recurrent otitis media: is a condition in which recurrent OME, AOM, atelectasis after VT was extruded and TP was heal, or VT was blocked o Non-inflammatory ear: a condition where the ear is still, dry, does not drain or falls out, without recurrent ear infections • Complications: Ear otorrhea, myringosclerosis, perforated TP, TP granuloma, medial migration, cholesteatoma After and 12 months, middle ear function was evaluated by tympanometry (non-perforated TP) and pure tone audiometry (cooperative children) • Type of tympanogram, according to Jerger’s classification • Audiogram pattern, hearing loss, PTA and ABG 2.2.5 Research tools Endoscope with color photography; pneumatic otoscope; Interacoustics AD226 monophonic audiometer; Tympanometer Interacoustics AT235, set of VTI; VT type bobbin fluoroplastic material 1-1.14 mm diameter; research record 2.2.6 Statistical analysis SPSS 23.0 software according to suitable statistical algorithms 2.3 Ethical approval Adhere to research ethics approved by the Ethics Council in Biomedical Research, Hanoi Medical University and Vietnam Cuba Hospital, Hanoi (No 187/HĐĐĐHYHN) 11 CHAPTER RESULTS 3.1 3.1.1 Middle ear function by endoscopy, tympanometry and pure tone audiometry Sample characteristics 3.1.1.1 Age and gender The median age was 26 months (12 months – 15 years) The group of 12-24 months was the most common one, found in 49/106 patients (46.2%) The group >5 years old had 18/106 patients (17.0%) Male had 62/106 patients (58.5%) The male/female ratio was 1.4/1 3.1.1.2 Characteristics of cleft palate Bilateral CP was in 75/106 patients (70.8%) The incomplete secondary cleft (type B) was the most common in 44/106 patients (41.5%) 3.1.2 Characteristics of middle ear disease 3.1.2.1 Characteristics of the number of infected ears Patients mainly had bilateral otitis media with 85/106 patients (80.2%) The relationship between the side of the ears with the side of the cleft or CP type, the difference was not statistically significant with p>0.05 3.1.2.2 Characteristics of middle ear by endoscopy Retracted TP was the most common with 164/212 ears (77.4%), TP in neutral position had 29/212 ears (13.7%) TP had changes in color, accounting for 147/212 ears (69.3%), of which 82/212 ears (38.7%) were opalescent and 62/212 ears (29.2%) were yellow There were 91/132 ears (68.9%) with reduced mobility There were 13/212 TPs with air bubbles or fluid levels (6.1%) The myringosclerosis was at 17/212 (8.0%) There were 8/212 TPs with signs of congestion (3.8%) The opaque TP was at 167/212 ears (78.8%) The absent light cone TP was at 97/212 ears (45.8%) There were 3/212 TPs perforated, accounting for 1.4% 12 3.1.2.3 Middle ear disease Chart 3.1 Distribution of middle ear disease (N=212) The rate of OME was 65.1% In the OME group, mucoid fluid was most common with 96/138 ears (69.6%) In atelectasis, only total atelectasis was found with grade II being the most common in 10/21 ears (47.6%) There was no difference between middle ear disease with side of cleft and CP type The difference was not statistically significant with p>0.05 OME was the most common, presenting in 71/98 ears (72.4%) of the 12-24 months group Atelectasis was seen in the group >5 years old, 14/36 ears (38.9%) The difference was statistically significant with p=0.050 3.1.3 Evaluation of middle ear function by tympanometry Chart 3.4 The relationship between tympanogram and middle ear disease 13 Tympanometry was performed for 209 ears with non-perforated TP The most common type B tympanogram was in 161/209 ears (77.0%) Type B was the most common in mucoid ear with 92/96 ears (95.8%) The difference was statistically significant with p0.05 3.1.4 Evaluation of middle ear function by audiometry Table 3.13 The relationship between audiogram and middle ear disease Audio- Nor- Cond- SensorMixed gram mal uctive ineural N Otitis Hearing n n n n media loss level Slight 0 Mild 15 1 17 OME Moderate N 24 28 Slight 0 Mild 1 Atelectasis Moderate 0 2 N 12 16 Normal 0 Normal Slight 0 N 0 There were 24 children who cooperated with 48 audiograms obtained The lowest age measured was 52 months The average PTA was 28.1±9.2dB, the average ABG was 18.4±7.3dB Mild conductive hearing loss was 20/48, accounting for 41.7% Moderate mixed hearing loss was 4/48 in ears (8.3%) PTA and ABG were higher in the OME and atelectasis groups than the normal group The difference was statistically significant with p0.05 14 3.2 3.2.1 Improvement of middle ear function after palatoplasty and ventilation tube insertion Sample characteristics 3.2.1.1 Palatoplasty 106 children were performed palatoplasty with 183 ears VTI 34 patients with type B cleft palate performed Langenback palatoplasty Cases of type C or D or large B were performed Veau - Wardill – Kilner surgery After months, 95/106 patients (89.6%) had palatoplasty achieved good results There were cases of imperfect closure with poor results of 4.7% 3.2.1.2 Characteristics of ears was perfomed ventilation tube insertion The VTI that were performed for OME was at 138/183 ears (75.4%), AOM was at 29/183 ears (15.8%); atelectasis was at 16/183 ears (8.7%) Type B tympanogram was found in 158/183 ears, accounting for 86.3% The average PTA was 28.98.4 dB The average ABG was 18.96.8 dB There were 20/42 ears with mild conductive hearing loss, accounting for 47.6% 3.2.2 Middle ear disease after palatoplasty and ventilation After months, 89 patients (156 ears) were re-examined After months and 12 months, there were 106 patients (183 ears) examined 3.2.2.1 Condition of the ventilation tube after surgery Ventilated and dried VTs were 116/156 ears (74.4%); 90/183 ears (49.2%) and 51/183 ears (27.9%) months, months and 12 months postoperative, respectively The highest prevalence of otorrhea in tube and obstructed tube at months after surgery were in 25/183 ears (13.7%) and 19/183 ears (10.4%), respectively Extruded VTs after months were in 22/156 ears (14.1%), months were in 49/183 ears (26.8%) and 12 months were in 110/183 ears (60.1%) 15 3.2.2.2 Characteristics of the tympanic membrane after surgery The rate of the neutral position were 145/156 ears (92.9%), 153/183 ears (83.6%) and 145/183 ears (84.7%) after months, months and 12 months, respectively The color of TP returned to opacity gray after months were at 142/156 (85.2%), months were in 144/183 (78.7%) and 12 months were in 121/183 (66.1%) Myrigosclerosis increased gradually over time After months, it was 25/156 ears (13.7%), months was in 36/183 ears (19.7%) and 12 months was in 40/183 ears (21.9%) 3.2.2.3 Middle ear status after surgery Table 3.21 Middle ear condition according to the status of ventilation tube months months 12 months Time (N=156) (N=183) (N=183) Retain- Extrud- Retain- Extrud- Retain- Extruded VT ed VT ed VT ed VT ed VT ed VT Middle n n n n n n ear status OME 17 37 AOM 3 Tube 25 13 otorrhea Perforated 2 Non121 15 103 23 56 68 inflamed N 134 22 134 49 73 110 The OME group before surgery: recurrent otitis media (OME, AOM) after months was 11/118 ears (9.3%); months was 22/138 ears (15.9%) and 12 months 35/138 ears (25.4%) The AOM group before surgery: recurrent otitis media (OME, AOM) after months was 5/29 ears (17.2%) and 12 months was 6/29 (20.7%) There were cases of recurrent otitis media in the atelectasis group after months and 12 months There were cases of perforated TM after extruded VT 16 The non-inflammatory ear in the good results palatoplasty group after months was at 123/133 (92.5%); months was at 116/140 (82.9%) and 12 months was in 113/150 (74.8%) The difference between recurrent otitis media and palatoplasty results was not statistically significant with p>0.05 After 12 months, the rate of non-inflamed ears in the group of >12 months retained VTs were in 56/61 ears, and the group of 3- months retained VTs were 13/19 ears The difference was statistically significant with p