PEDIATRICS Vol. 117 No. 6 June 2006, pp. e1119-e1123 (doi:10.1542/peds.2005-2520)
Clinical Manifestations and Risk Factors of Children Receiving Triple Ventilating Tube Insertions for Treatment of Recurrent Otitis Media With Effusion
Department of Otolaryngology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
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OBJECTIVE. Our goal was to determine risk factors for children receiving additional ventilating tube insertions after initial tube insertion and to determine the changes of clinical manifestations in children who have undergone 3 ventilating tube insertion procedures.
STUDY DESIGN. We retrospectively analyzed medical and operation records of 423 young patients who had ventilating tube insertion because of chronic otitis media with effusion from January 1993 to December 1998. The single-operation group included patients who had 1 ventilating tube insertion only, and the triple-operation group included patients who received ventilating tube insertion 3 times because of recurring chronic otitis media with effusion.
RESULTS. At the first operation, there were significant differences between the single- and triple-operation groups in mean age, the proportion who received a concurrent adenoidectomy, the mean indwelling period of the first ventilating tube, the proportion who developed postoperative otorrhea within 1 month, and the proportion who had early extrusion of the ventilating tube within 3 months of surgery. In the triple-operation group, the accumulated number of adenoidectomies, the indwelling period of the ventilating tube, and the time interval before subsequent ventilating tube insertion after ventilating tube extrusion significantly increased as ventilating tube insertion procedures were performed repeatedly. Although there was no difference when compared with the single-operation group, the proportion of glue-like effusion significantly decreased as ventilating tube insertion procedures were performed repeatedly. There were no significant differences between the single- and triple-operation groups in male/female ratio, site of ventilating tube insertion, and the proportion of patients with glue-like effusion at the first ventilating tube insertion.
CONCLUSIONS. The probability of receiving additional ventilating tube insertion because of recurrent otitis media with effusion significantly increased in younger patients at the time of first ventilating tube insertion. The concurrent adenoidectomy, duration of the ventilating tube, postoperative otorrhea within 1 month, and early extrusion of the ventilating tube also influenced the probability of additional ventilating tube insertion.
Key Words: otitis media with effusion • ventilating tube • glue ear
Abbreviations: OME—otitis media with effusion • VTI—ventilating tube insertion • ET—eustachian tube
Otitis media with effusion (OME) is the most common cause of hearing loss in children today and may, therefore, cause hearing loss at a critical time with respect to language and speech development in children.1 OME has a bimodal frequency distribution when plotted against age, with the number of cases peaking at 2 and 5 years of age.2 The treatment modality consists of watchful waiting, surgical intervention, or antibiotic treatment under certain restrictions. Ventilating tube insertion (VTI) is one of the most frequently performed treatments for OME, and maintenance of ventilating tubes for >3 months is well accepted.3
The main reason for performing VTI surgery is for immediate restoration of hearing to prevent or minimize developmental impairment in children with OME. Treatment with a ventilating tube can have adverse effects, such as otorrhea and scarring of the tympanic membrane.4,5 However, 
20% of children who underwent VTI required additional VTI within 2 years of their first procedure.6 Although there is much information available concerning the indications for and the complications of VTI, few data are available regarding the need for subsequent VTI after initial VTI in the pediatric population, and it is difficult to distinguish between children who will develop chronic or recurrent OME from those who will develop transient OME.7 Our aims with this study were (1) to determine risk factors that account for additional VTI in children who have undergone initial placement of a ventilating tube, and (2) to evaluate the clinical changes in children who have undergone VTI 3 times as a result of recurrent OME.
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METHODS |
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Study Design and Diagnosis of OME
With the approval of our institutional review board, we performed a retrospective analysis of medical and operative records of young patients who underwent VTI because of OME within faculties of the otolaryngology department at the Asan Medical Center. A total of 423 patients (288 male, 135 female) attending the center from January 1993 to December 1998 were included in this study, and the mean follow-up period was 5.2 ± 1.5 years (range: 2.7–9.9 years).
OME was defined as otitis media with middle ear effusions of any color, but without fever, otalgia, or otorrhea. The diagnosis was performed by an experienced otolaryngologist with an ototelescope as the mainstay of confirmation, in combination with a type B tympanogram or pure tone audiometry. If the child was too young or failed at audiometric testing, the diagnosis was based solely on ototelescopic findings and patient history.
VTI and Follow-up
VTI procedures were performed when there was prolonged middle ear effusion >3 months in bilateral OME cases or >6 months in unilateral cases despite 2 or 3 weeks of antibiotic treatment initially. The surgical procedures were performed under general or local anesthesia in a similar fashion. During the procedure, the ear canal was cleaned of foreign debris and cerumen, and an anteroinferior quadrant incision was made with a myringotomy knife. Middle ear effusion, if present, was aspirated and collected for observation before tube insertion. Ventilating tubes with a 1.14-mm internal diameter (Paparella type I, Medtronic Xomed Inc, Jacksonville, FL) were used. Adenoidectomy was considered when hypertrophied adenoid was notified on skull lateral radiograph film or the second or third time that VTI was performed with adenoid-associated symptoms.
Patients were examined by the otologist 1 week after the first VTI procedures and then instructed to revisit for examination every 3 months. Every otorrhea episode was registered per ear and per ventilating tube. The indwelling period of each ventilating tube was recorded in months from its insertion to the time point when last observed to be extruded or when removed. Ventilating tubes were removed from the tympanic membrane before spontaneous extrusion only in the following cases: (1) it had been in place for >2 years with no problems during the last 12 months, (2) there was a perforation considerably larger than the ventilating tube, or (3) there was granulation tissue around the ventilating tube that was resistant to local treatment.
Division of Patients According to the Number of Operations
The single-operation group (252 patients with 486 ears: 252 right ears and 234 left ears) included patients who underwent VTI 1 time only, and there was no evidence of chronic OME for >2 years after ventilating tube extrusion. The triple-operation group (171 patients with 276 ears: 150 right ears and 126 left ears) included patients who underwent VTI 3 times because of recurrence of OME after initial tube extrusion. Additional operations were performed only when there was prolonged middle ear effusion >3 months in bilateral OME cases or >6 months in unilateral cases.
Statistics
All of the values are expressed as mean ± SD or percentage. Data were analyzed using SigmaStat version 3.1 (Systat Software Inc, Point Richmond, CA). To compare between the single- and triple-operation groups, the unpaired t test and Fisher's exact test were used to analyze respective statistical values. To analyze the changes of clinical aspects in the triple-operation group, the test for linear trend was used for indwelling period of ventilating tube, percentage of glue-like effusion, postoperative otorrhea within 1 month, and extrusion of ventilating tube within 3 months postoperatively according to repeated VTI in the triple-operation group. Binary logistic regression analysis was used to determine which factors contributed to the prediction of outcome of treatment. These analyses were performed using SPSS, Inc for Windows, release 13 (SPSS, Inc, Chicago, IL). P values of <.05 were considered statistically significant.
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Differences Between Patients in the Single- and Triple-Operation Groups
There were significant differences in mean age at first operation (5.4 ± 1.9 vs 4.1 ± 2.2 years; P < .001; Table 1). A total of 129 (30%) patients in this study had adenoidectomy performed at the time of their first VTI procedures. Significantly more patients in the single-operation group (39.3%) than the triple-operation group (21.1%) underwent concurrent adenoidectomy (P < .001).
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The mean indwelling period of the first ventilating tube was 13.6 ± 5.7 vs 9.9 ± 6.0 months between the single- and triple-operation groups (P < .001). Triple-operation–group patients had a significantly higher rate of postoperative otorrhea within 1 month (5.4%) and rate of extrusion of ventilating tube within 3 months (4.4%) after the first VTI procedure than in the single-operation group (0.6% and 1.2%; P < .001 and P < .05, respectively). However, there was no significant difference between the single- and triple-operation group in the proportion of glue-type effusion at the time of the first VTI. When we applied logistic regression analysis using these parameters, the indwelling period of first ventilating tube (odds ratio: 0.90 for increase of 1 month; 95% confidence interval: 0.87–0.92; P < .00001) and postoperative otorrhea (odds ratio: 8.93; 95% confidence interval: 2.0–28.3; P = .003) were the independent variables for predicting the possibility of triple operation.
Changes of Clinical Aspects With Repeated VTIs in the Triple-Operation Group
Although the percentage of adenoidectomy at first VTI in the triple-operation group was significantly lower than in the single-operation group, the accumulated percentage of adenoidectomy increased from 21.1% to 36.8% at the third operation, which was similar to the percentage in single-operation group (Table 2). The mean ventilating tube indwelling period was significantly increased from 9.9 ± 6.0 months at the first operation to 12.8 ± 10.8 months at the third operation (P < .05). Although there was no significant difference in the proportion of patients with glue-like effusion at the time of first VTI between the single- and triple-operation group, the proportion of ears in the triple-operation group with glue-like effusion significantly decreased from 46.7% at the first operation to 35.9% at the third operation (P < .05). There were no significant differences in the proportion of patients with postoperative otorrhea within 1 month and extrusion of the ventilating tube within 3 months after each VTI procedure in the triple-operation group. The time interval before subsequent VTI after ventilating tube extrusion increased from 16.7 ± 8.9 months before the second VTI after the first ventilating tube extrusion to 19.2 ± 13.2 months before the third VTI after the second ventilating tube extrusion (P < .05).
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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OME is characterized by a high rate of spontaneous recovery but also by a high rate of recurrence.3 In recent studies, regardless of whether children with persistent early life OME receive VTI, they had poorer hearing at age 6 than do children who had less or no OME.1 OME is a multifactorial disease.8 It has long been recognized that eustachian tube (ET) dysfunction or obstruction predispose individuals to OME, and recurrent OME has been correlated with the maturation of the anatomic and physiologic structures of both the ET and the immune system.6 Studies have documented that the predisposing factors for development of OME are low birth weight, small skull circumference, and short birth length2 and that the predisposing factors for development of recurrent OME are young age, glue-like effusion, immunologic status, allergy, parental smoking, atopic disease, enlargement of adenoids, and recurrent acute infection.3,9–12
In this study, patients in the triple-operation group were significantly younger than patients in the single-operation group. The highest prevalence of otitis media occurs in the 6- to 36-month age range and decreases thereafter. Given that the typical ventilating tube will remain functional for 1 year, it should be expected that children undergoing their first VTI procedure at a younger age would be at increased risk for subsequent procedures.
In the present study, concurrent adenoidectomy at initial VTI was observed to reduce the need for subsequent VTI. The rationale for adenoidectomy in the treatment of OME includes the reduction of nasal obstruction, improved ET function, and removal of a chronic nidus of infection from the nasopharynx. Clinical trials have demonstrated the efficacy of adenoidectomy in reducing the morbidity of chronic OME in older children.3,13,14 The clinical practice guidelines on OME suggest that when a child becomes a surgical candidate, tympanostomy tube insertion is the preferred initial procedure and that adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis).15 Although the percentage of adenoidectomy at first VTI in this study was significantly lower in the triple-operation group, these values increased to those of the single-operation group with additional procedure.
The functional time of a ventilating tube depends partly on its type. The mean insertion duration for conventional, short-term tubes varies from 5.5 to 10.7 months16 and for long-term tubes from 20.6 to 35 months.17 In this study, the mean indwelling period for the Paparella type I ventilating tubes was 12.3 months. The single-operation group had a significantly longer mean ventilating tube indwelling period than the triple-operation group (13.6 vs 9.9 months; P < .001) after the first VTI procedure. Despite a significantly shorter indwelling period of ventilating tube at first VTI in the triple-operation group, these values lengthened to those of the single-operation group with additional procedure. In addition, the rates of postoperative otorrhea within 1 month and early extrusion of ventilating tube within 3 months after the first VTI procedure were significantly higher in the triple-operation group than in the single-operation group. Previous data also show that postoperative otorrhea during the first VTI significantly increased both the tube extrusion rate and the need for subsequent VTI.18
The type of fluid found in the middle ear during VTI procedures in cases of OME varies from a thick mucous "glue-like" secretion to thin serous fluid. Analysis of the constituents of the effusion shows that the viscosity is correlated with the concentration of mucin.19 A previous study suggested that different effusions because of various levels of enzymes and proteins correlate with recurrent cases of OME,20 whereas another study insisted that the type of effusion found on aspiration before VTI had no prognostic value.21 In this study, there was no significant difference in the proportion of glue-like effusion between triple and single-operation groups. However, the percentage of glue-like effusion decreased with repeated VTI procedure.
In this study, we showed that the probability of receiving additional VTI because of recurrent OME significantly increased in younger patients at the time of first VTI. The concurrent adenoidectomy, duration of the ventilating tube, postoperative otorrhea within 1 month, and early extrusion of the ventilating tube also influenced the probability of additional VTI. With repeated VTI, the accumulated number of adenoidectomies and indwelling duration of the ventilating tube came close to those of the single-operation group.
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ACKNOWLEDGMENTS |
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We thank Professor Tae Yong Kim for his advice for improving this article.
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FOOTNOTES |
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Accepted Nov 23, 2005.
Address correspondence to Tae Hyun Yoon, MD, PhD, Department of Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Pungnap-2 dong Songpa-gu, Seoul 138-736, Korea. E-mail: thyoon{at}amc.seoul.kr
The authors have indicated they have no financial relationships relevant to this article to disclose.
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PEDIATRICS (ISSN 1098-4275). ©2006 by the American Academy of Pediatrics
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