Ventilation Tube Extrusion Research Articles

Safety, tolerability, and effect of a single aural dose of Dornase alfa at the time of ventilation tube surgery for otitis media: A Phase 1b double randomized control trial

BackgroundOne third of children require repeat ventilation tube insertion (VTI) for otitis media. Disease recurrence is associated with persistent middle ear bacterial biofilms. With demonstration that Dornase alfa (a DNase) disrupts middle ear effusion biofilms ex vivo, we identified potential for this as an anti-biofilm therapy to prevent repeat VTI. First, safety and tolerability needed to be measured. MethodsThis was a phase 1B double-blinded randomized control trial conducted in Western Australia. Children between 6 months and 5 years undergoing VTI for bilateral middle ear effusion were recruited between 2012 and 2014 and followed for two years. Children's ears were randomized to receive either Dornase alfa (1 mg/mL) or 0.9 % sodium chloride (placebo) at time of surgery. Children were followed up at 2 weeks post-VTI and at 3-monthly intervals for 2 years. Outcomes assessed were: 1) safety and tolerability, 2) otorrhoea frequency, 3) blocked or extruded ventilation tube (VT) frequency, 4) time to blockage or extrusion, 5) time to infection recurrence and/or need for repeat VTI. ResultsSixty children (mean age 2.3 years) were enrolled with 87 % reaching study endpoint. Treatment did not change otorrhoea frequency. Hearing improved in all children following VTI, with no indication of ototoxicity. Dornase alfa had some effect on increasing time until VT extrusion (p = 0.099); and blockage and/or extrusion (p = 0.122). Frequency of recurrence and time until recurrence were similar. Fourteen children required repeat VTI within the follow-up period. ConclusionA single application of Dornase alfa into the middle ear at time of VTI was safe, non-ototoxic, and well-tolerated. Trial registrationACTRN12623000504617.

Factors Affecting the Extrusion Rate and Complications After Ventilation Tube Insertion: A Multicenter Registry Study on the Effectiveness of Ventilation Tube Insertion in Pediatric Patients With Chronic Otitis Media With Effusion-Part II.

The impacts of ventilation tube (VT) type and effusion composition on the VT extrusion rate and complications in children with otitis media remain unclear. This part II study evaluated the factors affecting the extrusion rate, recurrence rate, and complications of VT insertion. A prospective study was conducted between June 2014 and December 2016 (the EVENT study [analysis of the effectiveness of ventilation tube insertion in pediatric patients with chronic otitis media]), with follow-up data collected until the end of 2017. Patients aged <15 years diagnosed with otitis media with effusion who received VT insertion were recruited at 15 tertiary hospitals. The primary outcomes were time to extrusion of VT, time to effusion recurrence, and complications. Data from 401 patients were analyzed. After excluding the. of long-lasting tubes (Paparella type II and T-tubes), silicone tubes (Paparella type I) exhibited a significantly longer extended time to extrusion (mean, 400 days) than titanium tubes (collar-button-type 1.0 mm: mean, 312 days; P<0.001). VT material (hazard ratio [HR], 2.117, 95% confidence interval [CI], 1.254-3.572; P=0.005), age (HR, 3.949; 95% CI, 1.239-12.590; P=0.02), and effusion composition (P=0.005) were significantly associated with the time to recurrence of middle ear effusion. Ears with purulent (mean, 567 days) and glue-like (mean, 588 days) effusions exhibited a shorter time to recurrence than ears with serous (mean, 846 days) or mucoid (mean, 925 days) effusions. The revision VT rates during follow-up were 3.5%, 15.5%, 10.4%, and 38.9% in ears with serous, mucoid, glue-like, and purulent effusions, respectively (P<0.001). The revision surgery rates were higher among patients aged <7 years than among those aged ≥7 years. Silicone tubes (Paparella type I) were less prone to early extrusion than titanium 1.0 mm tubes. VT type, patient age, and effusion composition affected the time to recurrence of effusion.

Factors Related to Ventilation Tube Extrusion Time in Children and Adults.

The aim of this study was to investigate the factors affecting extrusion time in both children and adults with ventilation tube (VT) insertion, providing useful information for clinicians for better decision-making, follow strategy, and potentially improve clinical outcomes for these patients. Data from patients receiving myringotomy with VT insertion from January 1, 2007, to June 30, 2012, were retrospectively collected and analyzed by the end of 2018. Various factors, including age, gender, history of VT insertion, tympanogram, size of VT used, local finding of tympanic membrane, hypertension, diabetes mellitus, hyperlipidemia, and postoperative ear infection, were included and analyzed to examine the effects of these factors on extrusion time. A total of 447 patients were included in this study (Child group-Adult group = 237:210). The overall average extrusion time was 225.85 days. In the subgroup analysis, the average time was 221.3 days and 231.0 days for children and adults, respectively. The results showed that the VT extrusion time was significantly longer in participants without a history of VT insertion and in those where larger sized VTs were inserted in both age-groups. Male gender had an influence on extrusion time in children. In addition, a history of VT insertion and VT size were determined to be factors related to extrusion before 12 months in children. History of VT insertion and VT size were significantly related to VT extrusion time in both children and adults and defined as factors associated with extrusion before 12 months in children. The findings suggest avoiding VT with a diameter < 1 mm and considering an appropriately larger size in patients with a history of VT insertion to optimize VT retention.

Is It Necessary to Treat Otitis Media With Effusion (OME) Prior to Cochlear Implantation? Results Over a Long-term Follow-up.

Evaluate the intra- and postoperative effects of untreated otitis media with effusion (OME) in cochlear implant (CI) patients, and to assess the role of ventilation tube (VT) introduction before implantation. A retrospective chart review. Tertiary referral center. CI patients, aged 10 years or younger, implanted during 2009 to 2013. Cases were divided into three groups: 1) normal aerated middle ear before CI, 2) OME treated with VT, and 3) untreated OME. Intraoperative and postoperative findings and complications. One hundred ninety-four cases (implanted ears) were included. Ninety-nine aerated, 39 treated with VT, and 56 with untreated OME. Mean age at implantation was 3.1, 2.1, and 1.6 years, respectively. Granulations and edema were significantly more common in untreated OME than aerated ears (62% vs. 7%, p <0.001). VT reduced the rate of these findings (46%) but not with statistical significance (p = 0.1) compared with untreated OME. Intraoperative findings were all manageable and were not associated with higher perioperative complication rates. The rates of early and late postoperative complications were low in all groups, with no significant differences between groups. Tympanic membrane perforations were encountered in two patients after VT extrusion. Rate of otorrhea was 20% during the first year after implantation and 5% at last follow up. Our results suggest that CI candidates with OME can be safely implanted without preimplantation VT insertion. Implanting patients with untreated OME allows earlier implantation. CI surgery can be more challenging in the presence of effusion; however, intraoperative findings are manageable.

Water precautions for prevention of infection in children with ventilation tubes (grommets).

Following middle ear ventilation tube (tympanostomy tube or grommet) insertion, most surgeons advise that a child's ears should be kept dry during the immediate postoperative period. Following the initial period some surgeons will permit swimming or bathing, whereas other surgeons will recommend ongoing water precautions. A large number of studies have been conducted to explore the association between water exposure and ear infections in children with ventilation tubes, however a range of differing conclusions exist regarding the need for water precautions and there is wide variation in clinical practice. To assess the effectiveness of water precautions for the prevention of ear infections in children with ventilation tubes (grommets), at any time while the tubes are in place. The Cochrane ENT Trials Search Co-ordinator searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); PubMed; EMBASE; CINAHL; Web of Science; Clinicaltrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 September 2015. Randomised controlled trials recruiting children (0 to 17 years) with ventilation tubes and assessing the effect of water precautions while the tubes are in place. We considered all forms of water precautions, including behavioural (i.e. avoidance or swimming/bathing restrictions) and mechanical (ear plugs/moulds or hats/bands). We used the standard methodological procedures expected by Cochrane. Our primary outcome measures were episodes of otorrhoea and adverse effects; secondary outcomes were antimicrobial prescriptions for ear infections, ventilation tube extrusion, surgical intervention to remove ventilation tubes and hearing outcomes. Two randomised controlled trials recruiting a total of 413 patients met the criteria for inclusion in our review; one study had a low risk of bias and the other study had a high risk of bias. Ear plugs versus control One study recruited 201 children (aged six months to six years) who underwent myringotomy and ventilation tube insertion. The study compared an intervention group who were instructed to swim and bathe with ear plugs with a control group; the participants were followed up at one-month intervals for one year. This study, with low risk of bias, showed that the use of ear plugs results in a small but statistically significant reduction in the rate of otorrhoea from 1.2 episodes to 0.84 episodes in the year of follow-up (mean difference (MD) -0.36 episodes per year, 95% confidence interval (CI) -0.45 to -0.27). There was no significant difference in ventilation tube extrusion or hearing outcomes between the two study arms. No child required surgical intervention to remove ventilation tubes and no adverse events were reported. Water avoidance versus control Another study recruited 212 children (aged three months to 12 years) who underwent myringotomy and ventilation tube insertion. The study compared an intervention group who were instructed not to swim or submerge their heads while bathing with a control group; the participants were followed up at three-month intervals for one year. This study, with high risk of bias, did not show any evidence of a reduction or increase in the rate of otorrhoea (1.17 episodes per year in both groups; MD 0 episodes, 95% CI -0.14 to 0.14). No other outcomes were reported for this study and no adverse events were reported. Quality of evidence The overall quality (GRADE) of the body of evidence for the effect of ear plugs on the rate of otorrhoea and the effect of water avoidance on the rate of otorrhoea are low and very low respectively. The baseline rate of ventilation tube otorrhoea and the morbidity associated with it is usually low and therefore careful prior consideration must be given to the efficacy, costs and burdens of any intervention aimed at reducing this rate.While there is some evidence to suggest that wearing ear plugs reduces the rate of otorrhoea in children with ventilation tubes, clinicians and parents should understand that the absolute reduction in the number of episodes of otorrhoea appears to be very small and is unlikely to be clinically significant. Based on the data available, an average child would have to wear ear plugs for 2.8 years to prevent one episode of otorrhoea.Some evidence suggests that advising children to avoid swimming or head immersion during bathing does not affect rates of otorrhoea, although good quality data are lacking in this area. Currently, consensus guidelines therefore recommend against the routine use of water precautions on the basis that the limited clinical benefit is outweighed by the associated cost, inconvenience and anxiety.Future high-quality studies could be undertaken but may not be thought necessary. It is uncertain whether further trials in this area would change the findings of this review or have an impact on practice. Any future high-quality research should focus on determining whether particular groups of children benefit more from water precautions than others, as well as on developing clinical guidelines and their implementation.

Trans-tympanic catheter insertion for treatment of patulous eustachian tube

ObjectivesTo evaluate the safety and therapeutic efficacy of trans-tympanic catheter insertion (TCI) in patients with refractory patulous eustachian tube (PET). MethodsTCI was attempted in thirty-six ears of twenty-nine patients with chronic PET refractory to conservative treatment. The catheter was inserted under local anesthesia in an operating room through the bony orifice of the eustachian tube (ET) to occlude the isthmus of the tube via a myringotomy site on the tympanic membrane. Patients were evaluated postoperatively by nasal endoscopy and by interview to document symptoms. Successful treatment was defined as complete relief or significant improvement plus satisfaction with treatment. Patients had no concurrent disease and did not undergo any additional surgical procedure. ResultsTCI was performed in all except one ear, in which it failed because of an abnormally narrow tympanic ET orifice. Follow-up durations ranged from 6 to 37months, with an average of 19.3months. Successful treatment of subjective autophony was achieved in twenty-nine (82.4%) of the thirty-five ears. Ventilation tube (VT) placement was performed in the two ears because of otitis media with effusion (OME) after TCI. In one ear, the inserted catheter was finally removed due to additional unilateral mastoiditis after VT extrusion. ConclusionTCI seems to be a minimally invasive and was used successfully to treat PET. The procedure had a good overall success rate and complications were rare in the long-term.

Risk factors for recurrent otitis media with effusion

Background/Aim. Otitis media with effusion (OME) is a common disease among the children aged from 6 months to 4 years, but recurrences are common after the extraction of ventilation tubes. The aim of the study was to determine the risk factors for recurrent OME after extraction of ventilation tubes. Methods. The research was a prospective study with 305 children aged 0 to 10 years with OME. Forty three (14%) of them had recurrent OME. We analyzed the factors that could lead to the redevelopment of the disease after extrusion of the tubes. Results. It was found that the majority of children with recurrent disease was between the ages of 5 to 7 years (56%) and had allergy in significantly higher rate than children without recurrence. In most cases (37.7%), the retention time of ventilating tube was above 10 months and the recurrent disease was diagnosed in 46.5% cases within a period of 10 to 12 months after extrusion of tubes. Conclusion. Children with OME and after ventilation tube extrusion need to be followed up for 1 year after the removal of tubes. It is necessary to inform the parents that the disease can recur. Children in the kindergarten, in preschool age and with a respiratory allergy had higher possibility for recurrent OME.

Interventions for adult Eustachian tube dysfunction: a systematic review.

Eustachian tube dysfunction (ETD) is the inability of the Eustachian tube (ET) to adequately perform at least one of its functions: to protect the middle ear from sources of disease, to ventilate the middle ear, and to help drain secretions away from the middle ear. There are a number of treatment options for ETD, but there is little consensus about management. To determine the clinical effectiveness of interventions for adult ETD and to identify gaps in the evidence to inform future research. Twelve databases were searched up to October 2012 for published and unpublished studies in English (e.g. MEDLINE from 1946, EMBASE from 1974, Biosis Previews from 1969 and Cumulative Index to Nursing and Allied Health Literature from inception). References of included studies, relevant systematic reviews and regulatory agency websites were checked. A systematic review was undertaken. Controlled studies evaluating prespecified treatments for adult patients diagnosed with ETD were eligible. Uncontrolled studies with at least 10 participants were included for interventions where no controlled studies were found. Outcomes included change in symptoms severity/frequency (primary outcome), quality of life, middle ear function, hearing, clearance of middle ear effusion, early ventilation tube extrusion, additional treatment, adverse events and complications. All aspects of the review process were performed using methods to reduce reviewer error and bias. Owing to heterogeneous data, a quantitative synthesis could not be performed, and results were reported in a narrative synthesis. Nineteen studies were included: three randomised controlled trials (RCTs) and two non-RCTs evaluating pharmacological interventions or mechanical devices for middle ear pressure equalisation; and 13 case series and one retrospective controlled before-and-after study evaluating surgical interventions. None was conducted in the UK. All studies were small (11 to 108 participants). Most non-surgical studies reported including mixed populations of adults and children. All except two studies were at high risk of bias, and subject to multiple limitations. Based on a single RCT, nasal steroids showed no improvement in symptoms or middle ear function for patients with otitis media with effusion and/or negative middle ear pressure. Very short-term improvements in middle ear function were observed in patients receiving directly applied topical decongestants or a combination of antihistamine and ephedrine. Single trials found two pressure equalisation devices were each associated with significant short-term improvements in symptoms, middle ear function and/or hearing. Eustachian tuboplasty (seven case series) and balloon dilatation (three case series) were associated with improved outcomes. Positive results were also reported for myringotomy (two case series), directly applied topical steroids (one case series) and laser point coagulation (one controlled before-and-after study). High rates of co-interventions were documented. Minor complications of surgery and pharmacological treatments but no serious adverse effects were reported. The evidence was limited in quantity and overall was of poor quality. No data were identified on several interventions despite extensive searches. It is not possible to draw conclusions regarding the effectiveness of any of the interventions for the treatment of adults with an ETD diagnosis, and there is insufficient evidence to recommend a trial of any particular intervention. Further research is needed to address lack of consensus on several issues, including the definition of ETD in adults, its relation to broader middle ear ventilation problems and clear diagnostic criteria. This study is registered as PROSPERO CRD42012003035. The National Institute for Health Research Health Technology Assessment programme.

Persistent perforation of the tympanic membrane following the extrusion of ventilation tubes

Persistent perforation of the tympanic membrane following the extrusion of ventilation tubes

Natural History of Pediatric Tympanic Membrane Perforation

To investigate the natural history of pediatric tympanic membrane perforation using an existing clinical database, with the aim of defining the time beyond which a perforation is unlikely to close naturally. Retrospective cohort study. Tertiary center. A database of pediatric ear, nose, throat, and audiology consultations containing 20 years of data was analyzed. A total of 2865 episodes of perforation were followed, with all cases of surgical reconstruction excluded. Cases of perforation after ventilation tube extrusion were tagged. Statistical techniques including survival analysis were used. Time from diagnosis of perforation to diagnosis of closure, in years. There was a predominance of perforations in boys (59.1% versus 40.9%). Time to closure increased by 7% for each 1-year increase in age at diagnosis. Time-to-closure curves for children older than 12 years diverged considerably from those for younger children after approximately 18 months. Centiles of time to closure were calculated for each 1-year age band. After 2.5 years of follow-up, rates of closure were 90% in children diagnosed younger than 7 years and 75% in children diagnosed between the age of 7 and 12 years. No significant difference was found in time to closure between boys and girls, left-sided and right-sided perforations, or in ventilation tube-related perforations and others. Comparison of membranes suffering a first perforation with those suffering a second perforation suggested a borderline significant time-to-closure disadvantage for first perforations. When faced with the clinical question of what period of watchful waiting would be appropriate in monitoring a perforated tympanic membrane, before intervention may reasonably be recommended; there seems to be little advantage in waiting longer than 2.5 years.

Factors affecting the persistence of tympanic membrane perforation developed with the extubation of ventilation tube

To determine which factors are associated with persistence of the tympanic membrane (TM) perforation detected after a spontaneous extrusion or surgical removal of a ventilation tube (VT). We conducted a retrospective chart review of all patients who underwent ventilation tube insertion from 1995 to 2003 at our institution. We identified 909 ears in which we could see the final state of TM and found 89 ears that fitted the inclusion/exclusion criteria. Various factors were analyzed to determine the factors associated with persistence of a TM perforation after VT extrusion or removal in 89 ears, including age at the time of tube extrusion or removal, sex, extubation pattern, intubation period, reason for VT insertion, history of previous VT insertions, condition of the TM when a perforation was detected, and previous adenoidectomy. Three factors were found to be statistically significant predictors of permanent perforation including age, extubation pattern and intubation period on univariate analysis. However, on multivariate analysis, extubation pattern, intubation period remained as statistically significant predictors. Our data shows that factors affecting the permanent TM perforation after the spontaneous extrusion or surgical removal of VT include extubation pattern and intubation period.

Does ENT outpatient review at 1-week post ventilation tube insertion improve outcome at 1 month in paediatric patients?

The aims of this study were to see if ENT review at 1 week following ventilation tube insertion in paediatric patients reduced the complication rate and the number of consultations with the general practitioner in the first postoperative month. Sixty-six children were prospectively randomized into two follow-up groups: group A was reviewed at 1 week and 1 month and group B at 1 month only. There was no statistically significant difference in postoperative otorrhoea (P = 0.59), ventilation tube patency (P = 0.44), ventilation tube extrusion rate (P = 0.64) and number of consultations with the general practitioners (GP) for postoperative otorrhoea (P = 0.19) between the two groups at 1 month. In conclusion, there seems to be no advantage with early postventilation tube insertion review as it does not reduce complications or decrease the GP consultation rate.

Adult-onset otitis media with effusion: results following ventilation tube insertion.

The outcome of otitis media with effusion (OME) in children is generally good. However, it is less clear in adults. All adult patients who had a ventilation tube inserted for OME at the Ipswich Hospital between 1996 and 1997 were studied. Of 53 patients studied, 28 had had a previous history of ventilation tube insertion. Furthermore, at 15-27 months following ventilation tube insertion, the ventilation tube had already extruded in 31 patients and the OME had already recurred in 19 of these. Endoscopic examination revealed that many patients still had evidence of inflammation at the lateral nasal wall (26.4 per cent) and at the eustachian tube orifice (51 per cent). There is also a strong history of atopy in the studied group and the skin prick test was positive in 57 per cent of the patients. This study shows that many patients with adult-onset OME have underlying pathology that could lead to recurrence of OME following ventilation tube extrusion.

Hearing aids versus ventilation tubes in persistent otitis media with effusion: a survey of clinical practice.

A postal survey was carried out to determine the current clinical practice amongst consultant otolaryngologists in the UK, regarding re-insertion of ventilation tubes or recommendation of hearing aids in cases of recurrence of otitis media with effusion (OME) after ventilation tube extrusion. Amongst the 319 respondents, 15 (4.70 per cent) routinely, 146 (45.77 per cent) sometimes, and 158 (49.53 per cent) either never, or very rarely, recommend hearing aids. Hearing aids and ventilation tubes were both suggested to be equally good options by some consultants but they preferred surgery for a number of reasons. There were inconsistencies in practice and some of the reasons for re-inserting ventilation tubes are not evidence-based. A hearing aid is a non-invasive option and this survey shows a need for a randomized control trial of hearing aids and ventilation tubes in the management of persistent and recurrent OME.

Fasciaform myringoplasty in children.

To evaluate the efficacy of fasciaform myringoplasty as a means to repair large tympanic membrane perforations in children. Retrospective review of the records of 26 patients who underwent 29 consecutive fasciaform myringoplasty surgeries over a 47-month period. Patients were followed up from 2 to 47 months postoperatively. Academic tertiary care children's hospital. Twenty-six patients (5 to 16 years old), with tympanic membrane perforations (25% to 95%) underwent a fasciaform myringoplasty procedure. The perforations were caused by extrusion of ventilation tubes (83%), deep retraction pockets, trauma, or repair after resection of cholesteatoma. The surgery involves resection of the native tympanic membrane and annulus. A new tympanic membrane is formed from formaldehyde-fixed autogenous temporalis fascia and positioned. Successful repairs, complications, and audiometric evaluations were analyzed. Fisher's Exact Test was used to compare complication rates by age. Successful closure was accomplished in 69% of cases. Otitis media recurred in 52%. Ventilation tubes were reinserted in 24%; 28% resolved with antibiotics alone. When tubes were placed through the graft, small residual graft perforations resulted. Audiometric evaluation revealed improvement in pure tone average to less than a 20-dB hearing level in 77% and reduction of the air-bone gap to within a 20-dB hearing level in 90% of those cases (10/29) with complete audiometric data. Fasciaform myringoplasty has proven to be a successful procedure for closing large tympanic defects and improving hearing acuity in the pediatric population. However, recurrent otitis media and eustachian tube dysfunction may continue. Rates of reperforation were statistically significantly higher in children 7 years old and younger. Conservative management of children in this younger age group is warranted.