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Analysis of tracheostoma morphology
Acta Oto-Laryngologica
Abstract
Objectives: Existing fixation methods of automatic speaking valves (ASVs) suffer from shortcomings which partly are the result of insufficient conformity of the intratracheal fixation method’s shape to the tracheostoma anatomy. However, quantitative data are lacking and will be helpful to analyse solutions for airtight fixation. This article provides such data.
Patients and methods: The tracheostoma morphology was measured in computerized tomography scans of 20 laryngectomized patients. Measured were transverse and sagittal diameters, transition angle between skin level and tracheostoma lumen and between the tracheostoma lumen to the trachea, TE valve placement and stoma depth.
Results: The mean transverse and sagittal diameters of the stoma at the peristomal lip are 19.2 mm [standard deviation (SD 5.2 mm)] and 17.6 mm (SD 5.3 mm), respectively. The mean transition angles are 84.5° (SD 15.6°) at skin level and 153.6° (SD 11.7°) into the trachea. The mean distance between TE valve and peristomal lip is 13.5 mm (SD 7.0 mm). The mean stoma depth is 14.0 mm (SD 6.4 mm).
Conclusions: Due to the large variation, no ‘average tracheostoma morphology’, suitable for shaping a generic intratracheal fixation device, can be defined. Therefore, providing an airtight fixation in each patient would require a large range of different sizes, customization or a new approach.
... As a fixation method for the HME and ASV, the laryngectomized patients can use either a peristomal adhesive (around the tracheostoma, Figure 1A), or alternatively, an intratracheal cannula or button (inside the tracheostoma). Disadvantages associated with these fixation methods, to an extend caused by the large inter-patient variations in tracheostoma morphology [6][7][8], are: poor fit, adhesive peeling, button dislodgement, skin irritation, tissue traumatization and air leakage. [2][3][4]6,7,9] These fixation problems become more pronounced during hands-free speech, as the ASV exerts more stress on the fixation method without the natural backpressure during manual occlusion. ...
... We conjecture that a PVA foam exterior thickness of approximately 7.5 mm, in combination with different sizes of intratracheal button, can potentially provide both a safe and effective ASV fixation in a range of tracheostoma morphologies; it provides enough fixation to withstand pressures of loud speech (approximately 6 kPa) without exerting excessive pressure which could lead to ischemic damage to the tracheal tissue (if the compression < 60% of the PVA foam's original thickness). Even though there are large inter-patient variations in tracheostoma morphology [6][7][8], the ITFD's deformable foam exterior could potentially resolve some disadvantages associated with the commercially available fixation methods without the need of a user-specific customization. [15] However, the simplifications made in this study limit the reliability and comparability of these results. ...
Permanent hands-free speech with the use of an automatic speaking valve (ASV) is regarded as the optimal voice rehabilitation after total laryngectomy. Due to fixation problems, regular ASV use in laryngectomized patients is limited. We have developed a novel intratracheal fixation device (ITFD), composed of an intratracheal button augmented by a hydrophilic PVA foam exterior around its shaft. The aim of this study was to evaluate the ITFD’s feasibility in vitro, defined as an effective ASV fixation without causing mucosal tissue traumatization.
We found that when the expanded PVA foam is compressed less than 60% of its original thickness, it can potentially provide both a safe and effective ASV fixation in a range of tracheostoma morphologies; enough fixation to withstand pressures related to loud speech (approximately 6 kPa) without exerting excessive pressure (>32 mmHg) which could lead to ischemic damage to the tracheal tissue.
This study demonstrates the feasibility of the ITFD in vitro that might improve stomal attachment of ASVs. The ITFD’s deformable foam exterior may provide an effective fixation in most laryngectomized patients, compared to commercially available fixation methods, without the need for a user-specific customization. The results of a clinical feasibility study in laryngectomized patients are pending.
... 5,[9][10][11][22][23][24][25][26][27][28][29] Currently available HMEs do not yet provide levels of humidification identical to those provided by the nose, and further improvements are needed. Problems associated with available adhesives, such as skin irritation, 30,31 poor seal, and different shapes and morphologies of tracheostomas, 8,32,33 have been described as additional reasons for reduced adherence. ...
Objective
To evaluate the effects of new devices—heat and moisture exchangers (HMEs) and adhesives—on pulmonary symptoms, subject adherence, quality of life, dermatologic symptoms, and patient satisfaction after laryngectomy.
Study Design
Prospective crossover study.
Setting
Between December 2020 and April 2021, 40 patients were enrolled who had undergone laryngectomy, routinely used HMEs and adhesive, and were followed in our Department of Otolaryngology–Head and Neck Surgery.
Methods
Patients were allocated into group A (new products) or group B (usual care) for 6 weeks. Then the 2 groups reversed, and each patient acted as his or her own control. Patients kept a diary and cough tally sheet. At baseline and after each 6-week period, 2 questionnaires were administered: EQ-5D (European Quality of Life–5 Dimensions) and CASA-Q (Cough and Sputum Assessment Questionnaire).
Results
Six weeks of using new products resulted in the following effects for both groups: (1) a significant reduction in daily forced expectoration and dry coughs, (2) a significant improvement in all domains of the CASA-Q, (3) an increase in adherence to HME use, (4) a significant reduction in shortness of breath and skin irritation, and (5) significantly better scores in the anxiety/depression domain of the EQ-5D.
Conclusion
Achieving this reduction in patients who were already highly adherent to HME use is clinically relevant and underscores the importance of using better-performing HMEs that can compensate for the humidification deficit. Improving pulmonary symptomatology could reduce patient restrictions in daily life and avoidance of social activity, with a consequent positive effect on quality of life.
El análisis facial y dental debe integrarse con todos los tratamientos dentales, donde la estética y la función deben ser los principales objetivos, ya que la cara es la base principal del equilibrio estético y la odontología debe estar sincronizada con ella. El objetivo de este trabajo es una revisión de la literatura para identificar los factores que deben considerarse en un análisis estético del paciente cuando se somete a un tratamiento den-tal. La percepción de una cara equilibrada es posible, existe un concepto diversificado de belleza facial, y esto varía según el paciente, el tratamiento estético debe ser siempre una función aliada, para que pueda mejorar la armonía facial con la sonrisa, devolver la estética positiva significa satisfacer las expectativas y dar una ima-gen positiva de sí mismo. La percepción de una cara equilibrada es posible, existe un concepto diversificado de belleza facial, y esto varía según el paciente. Se concluye que la percepción de un rostro equilibrado es posible, existe un concepto diversificado de belleza facial y esto varía según el paciente.
To describe trends and 4-year survival rate of surgical and nonsurgical treatment for laryngeal cancer.
Observational cross-sectional study.
A total of 131 694 cases of laryngeal cancer diagnosed from 1985 to 2007 identified from the National Cancer Database.
Primary treatment information, including radiation therapy (RT), chemoradiation (CRT), and curative intent surgery, were identified. The association between treatment and the patient's clinical and nonclinical variables was analyzed using univariate and multivariate statistics. The 4-year survival rate was generated through Kaplan-Meier estimates, and multivariate Cox proportional hazard models were used to generate hazard ratios.
Among patients with early-stage cancer, the proportion receiving primary surgery increased (from 20% in 1985 to 33% in 2007), whereas the use of RT decreased from 64% to 52%. Patients with early-stage cancer who resided in areas with higher socioeconomic status (SES) zip codes, had private insurance, who were not African American, and who were treated at academic facilities were more likely to receive surgery. The 4-year survival rate for patients with early-stage laryngeal cancer treated with surgery was higher than the rate for those treated with RT (79% vs 71%). Among patients with advanced-stage cancer, the use of CRT increased from less than 7% to 45%, whereas the use of total laryngectomy decreased from 42% to 32%. The use of CRT was more common among patients who resided in areas with higher SES zip codes, had private insurance, and who were younger. The 4-year survival rates for patients with advanced laryngeal cancer treated with total laryngectomy, CRT, and RT were 51%, 48%, and 38%, respectively. Factors associated with an increased risk of death from advanced laryngeal cancer included receiving CRT and race/ethnicity.
Among patients with early-stage laryngeal cancer, we observed an increasing proportion of primary surgical therapy during this study period. Among patients with advanced-stage cancer, we observed an increasing proportion of CRT. Not only were clinical factors associated with type of treatment, but select sociodemographic elements were also associated with treatment. Further investigation as to the decision-making process of patients with different sociodemographic backgrounds will assist in mitigating the differences in survival for this group of patients.
3D stereophotogrammetry is a useful tool for quantitative assessment of tracheostoma anatomy, and thus in future could possibly play a role in solving current problems with peristomal and intratracheal fixation of stoma appliances.
Differences in tracheostoma anatomy between laryngectomized patients are held partly responsible for the differences in duration of attachment of standard peristomal adhesives for heat and moisture exchangers (HMEs) and automatic stoma valves (ASVs). Accurate information on a set of basic stoma anatomy parameters should be helpful to overcome fixation problems in individual patients and in the general laryngectomy population.
This was an exploratory observational pilot study in 20 laryngectomized patients. Three-dimensional (3D) images of the tracheostoma and surrounding tissue were captured with a 3D digital camera, which applies the advanced principles of stereophotogrammetry. Data were analysed by using a 3D editing program. The following tracheostoma parameters were measured for each patient: horizontal and vertical diameters, circumference, depth and surface.
Inter-observer outcomes show a mean stoma circumference of 58.2 mm (SD 11.6 mm). The mean surface was calculated at 186.6 mm2 (SD 61 mm2). The mean size of the stoma's horizontal diameter and vertical diameter was 14.7 mm (SD 2.9 mm) and 19.0 mm (SD 3.4 mm), respectively. The mean depth of the stoma in relation to the right sternal head of the m. sternocleidomastoideus was 15.5 mm (SD 5.4 mm) and in relation to the left it was 16 mm (SD 5.6 mm).
In most patients with advanced or recurrent laryngeal or hypopharyngeal cancer, total laryngectomy is indicated. This means the loss of three main functions: phonation; respiration; and the prevention of aspiration during deglutition. Laryngectomy patients have various options to restore phonation: an oesophageal voice; an electrolaryngeal voice; or a tracheo-oesophageal voice. In the last case a silicone rubber shunt valve is placed in the tracheo-oesophageal wall and phonation is generated when exhaled air is forced through the oesophagus and neopharynx. This method is widely applied in Western Europe. In this paper we review the literature on fixation problems with shunt valves, tracheostoma valves and heat and moisture exchange (HME) filters. Tracheo-oesophageal speech without a valve is not considered. Despite 22 years of experience with the implantation of tracheo-esophageal shunt valves and many improvements in the design, problems still remain, such as biofilm formation with subsequent leakage through the valve, the need for frequent and inconvenient replacements, fistula enlargement leading to leakage around the device and reduced fixation, and infections. The high cost of shunt valves is a drawback to their use worldwide. To enable hands-free speech, different types of tracheostoma valve have been developed. These valves are fixed to the skin or to the tracheostoma by means of an intra-tracheal device. An HME filter is used to protect the airway and maintain physiological balance. Such devices are only suitable for a selected group of patients as fixation to the skin or trachea can be a major problem. Speaking and coughing cause pressure increases, which often result in mucous leakage and disconnection of the valve and/or HME filter. Recommendations are made for future improvements in fixation techniques.
At the moment, there is an inadequate margin fit of commercially available stoma buttons. The aim of the present study was to develop a customized short tracheal cannula based on digital data. Furthermore, the applied material has to be evaluated considering germ colonization and appropriate cleaning procedures.
Computed tomographies of 53 patients who underwent laryngectomy were surveyed. Based on the digital data, a customized short tracheal cannula was created and manufactured from silicone. The new cannula was incorporated in ten patients and worn for 4 weeks. A clinical examination of an otolaryngologist and subjective assessment of the patients were carried out. Furthermore, microbiological test considering germ colonization was performed.
The customized short tracheal cannula could be incorporated in all patients. The clinical results showed no irritation or mucosal lesions. The subjective individual evaluation by the patients was promising. The proposals for improvement could be considered. The microbiological examination revealed a higher contamination of the silicone compared to the silver cannulas. Both chemical and mechanical decontamination showed sufficient results.
A workflow for development and manufacturing of a customized short tracheal cannula from digital data could be established. The cannula is compatible to standard equipment and routine cleaning procedures. Clinical studies are required to evaluate the potential benefit for patients.
Background
Most patients perceive total laryngectomy as a mutilation carrying with it a loss of physical and psychological integrity. Thus, an artificial larynx system that can replace the laryngeal functions would significantly improve the quality of life for the afflicted patients. Methods
This report, with accompanying video, presents the first case in an ongoing clinical trial of laryngeal rehabilitation using an artificial larynx after total laryngectomy for squamous cell carcinoma, for an 8-month follow-up period. We depict the prosthesis' features, our 2-step surgical procedure, and the outcome. The prosthesis is formed of 2 parts: (1) a tracheal prosthesis with a porous titanium junction with trachea, which was implanted in the first step to ensure its colonization, and (2) a removable part composed of concentric valves that enable inhalation and exhalation. The second part was implanted endoscopically. The implant was monitored with a retrograde nasofibroscopy of the tracheal prosthesis lumen and CT scans over a course of 8 months. ResultsThe patient's functioning in the relevant postoperative problem areas, such as swallowing, breathing, and smelling, has significantly improved. The patient was able to talk in a whispering fashion while the tracheostomy was temporarily closed. The implant's porous part was in the process of being colonized by the surrounding tissue and no fistulas were observed as evidenced by barium swallow. Conclusion
As the current case shows, tracheotomy closure can be performed, and laryngeal functions are restored, by means of an implant. With further improvements, this system can alleviate the need for a permanent tracheostomy after total laryngectomy, while maintaining important larynx functions intact. (c) 2014 Wiley Periodicals, Inc. Head Neck 36: 1669-1673, 2014
Tracheoesophageal (TE) speech using a voice prosthesis and hands-free speaking valve with an intraluminal attachment is the gold standard for voice restoration after total laryngectomy. Modification of a standard self-retaining silicone cannula or laryngectomy button often aids in the attachment of a speaking valve within the tracheal lumen for hands-free TE speech production. An increased number of laryngectomized individuals are able to achieve hands-free TE speech when the standard length, flange, and diameter of a silicone button is customized to accommodate individual tracheostomal contours. A technique is presented for modification of a standard silicone laryngectomy button to facilitate hands-free TE speech after total laryngectomy.
Total laryngectomy patients who depend on a prosthesis for the production of alaryngeal speech often have irregular peristomal anatomy. The standard tracheostoma (speech) valve retainer cannot be intimately adapted to uneven and highly mobile tissue. Fabrication of a custom speech valve retainer is indicated under such circumstances but may be complicated by restricted access to the surgically created stoma. This article describes the clinical and laboratory techniques for the fabrication of a custom tracheostoma valve retainer that displaces the peristomal soft tissues and musculature. This technique permits access for placement of the speech valve and valve retainer in close proximity to the speech button prosthesis. Enclosure of the custom retainer in the recess underlying the peristomal musculature also provides a plug that enhances retention and increases patient confidence during alaryngeal speech. The coordinated efforts of the speech specialist and the prosthodontist in the fabrication of this prosthesis enhances the quality of life for the total laryngectomy patient.
Laryngectomized, tracheoesophageal speakers who achieve hands-free speech wear a special breathing valve to automatically shunt air into the pharyngoesophagus for speech production. The standard method of attachment is adherence to the peristomal skin with glues and adhesives. The Barton button is a simpler, more efficient alternative that provides intraluminal attachment within the trachea. Although the device is appealing, constraints in standard design and dimensions have limited its success. This article presents a technique for modification of the Barton button to increase its successful use by tracheoesophageal speakers.
With the use of a new automatic stoma valve (ASV) it appears possible to rehabilitate patients who have previously been unsuccessful in acquiring hands-free speech. As well as making daily ASV use possible for an additional group of patients, this new device was also appreciated by many patients as an additional rehabilitation tool for specific occasions. Despite statistically significant improvements in aspects of voice and breathing using this novel ASV, improvement of peristomal adhesion is probably the main factor needed to further increase success rates. Nevertheless, our results show that it makes sense to keep trying to achieve hands-free speech, even if previous attempts have failed.
To make a long-term (6 months) assessment of compliance and aspects of voice, breathing and quality of life using a new ASV: the Provox FreeHands heat and moisture exchanger (HME).
This was a prospective clinical multicentre trial in 79 laryngectomized patients (8 regular ASV users, 58 previously unsuccessful users and 13 new users). Data were collected at baseline and after 1 and 6 months by means of European Organization for Research and Treatment of Cancer Quality of Life questionnaires and specific structured questionnaires concerning compliance, skin adhesion, voicing and pulmonary aspects. An objective assessment of voice parameters (maximum phonation time, maximum phonation time while counting, dynamic loudness range and number of pauses in a standard read-aloud text) was made for comparison of different stoma occlusion methods (digital occlusion via an HME and two different ASVs). A subjective assessment of overall voice quality was made.
After 6 months, 19% of patients used the new ASV on a daily basis (mean 5 h/day), while 57% used it on an irregular basis as an additional rehabilitation tool for special occasions. Two-thirds of the study group indicated that they would continue to use the new ASV after the study period. With respect to the objective parameters, statistically significantly better maximum phonation times and dynamic loudness ranges were observed with the new ASV compared to the Blom-Singer ASV. However, the best results for all the objective parameters were obtained with digital occlusion via the Provox HME.
Excellent results have been reported with the use of voice prostheses for the rehabilitation of laryngectomees. Patients, however, consider it a disadvantage that the tracheostoma must be closed manually for speech production. This limits their ability to simultaneously communicate by gesture or to work with both hands. An automatic tracheostoma valve helps patients overcome this problem. We describe a prospective clinical trial evaluating our experience with the Provox FreeHands HME Automatic Tracheostoma Valve system. Twenty-four laryngectomees were randomly selected from the patients who had undergone laryngectomy at the ENT Department. Immediately, after 4 weeks and 6 months later having been fitted with a Provox FreeHands HME, the patients were asked to complete a questionnaire in order to assess their satisfaction, voice quality, wearing comfort, fixation, potential problems, and the effectiveness of the HME cassette. In addition, we investigated relevant voice quality parameters including dynamics range, frequency range of the speaking voice, and maximum phonation time. Seven patients discontinued the study due to problems of securing the valve to the skin (four patients) or recurrent cancer (three patients). Ten of the remaining 17 patients wore the valve daily for an average of 8.4 h. A total of 88% of the patients considered it a great advantage to be able to speak without having to use their hands. With the Provox FreeHands HME, maximum phonation time was 8.7 (+/-6.2) s and the dynamic range was 21.9 (+/-5.8) decibels. The results show that the Provox FreeHands HME Automatic Tracheostoma Valve system not only allows hands-free speech but is also associated with excellent compliance and good voice rehabilitation.
This newly developed tracheostoma button and fixation system was appreciated by the majority of the patients in this study and led to an increased use of automatic speaking valves (ASVs).
Development and prospective clinical evaluation of a new tracheostoma button and fixation system to enhance hands-free speech in laryngectomized patients.
The Provox LaryButton and LaryClip adhesive system were prospectively evaluated in 11 patients: 10 male, 1 female; mean age 60.5 years, range 46-80 years; median follow-up since laryngectomy 4.9 years, range 9 months to 21 years. A study-specific questionnaire was used and the observation period was 3 weeks.
Eight patients were compliant, three dropped out of the study. The LaryClip adhesive system was tried by seven of these compliant patients, and ultimately used by six. At the start of the study two patients used an ASV on a daily basis, three alternated between an ASV and regular, manually operated heat and moisture exchangers (HME), three only used a HME. At the end of the study, three used the ASV daily, five alternated between ASV and HME. Seven patients indicated that they would continue using the new system, six with clips and one with the button only.
To compare the quality of life (QoL) of patients who underwent total laryngectomy with voice prosthesis insertion and postoperative radiotherapy (PORT) with those receiving concurrent chemoradiation for laryngeal preservation.
Retrospective, cross-sectional study in a tertiary academic center.
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaires were used to assess long-term QoL in 67 patients treated for laryngeal cancer.
The scores of functional scales for physical (P < .000), social (P = .001), and role functioning (P = .043) were more favorable in the chemoradiation group. The global QoL score was higher in the nonsurgical group (P = .016). Surgical patients reported on sleep disturbance (P < .000), dyspnea (P = .001), and pain (P = .003), with a higher scores and greater difficulties with the senses (P < .000), social contact (P = .002) and speech (P = .010). The chemoradiation group reported greater problems with dry mouth (P < .000) and sticky saliva (P = .005).
We found better long-term QoL scores in patients undergoing concurrent chemoradiation. This appears to be mainly because of better physical functioning, social functioning, and social contact and smaller problems with pain, respiration, speech, the senses, and sleep disturbances.
Development of a handsfree speech valve for laryngectomy patients. [Dissertation]. The Netherlands: University of Groningen
- Eb Van Der Houwen