Pulmonary Rehabilitation after Total Laryngectomy
During a total laryngectomy, the entire larynx is removed, which leads to a permanent disconnection of the upper and lower airways and a permanent tracheostoma in the neck. Subsequently, among others, these anatomical changes lead to changes in voice production, breathing, and olfaction.
Post-laryngectomy pulmonary function
After a total laryngectomy, the patient breathes in and out through the tracheostoma in the neck. Therefore, the nasal functions of warming, humidifying, and filtering of the inhaled air are lost. During normal nasal breathing, typically air of 22oC and 40% Relative Humidity (RH) is during inspiration conditioned into air of 32oC and 99% RH at the level of the trachea (Ingelstedt, 1956). Due to the loss of the air-conditioning functions of the upper airways, these numbers are much lower in laryngectomized patients. Air of 22oC and 40% RH is only conditioned to 27-28oC and 50% RH at the level of the upper trachea (Keck, Durr, Leiacker, Rettinger, & Rozsasi, 2005). Both temperature and humidity have a significant impact on the ciliary activity in the trachea. Studies in a rabbit model have shown that at body temperature (37oC) the cilia stop beating when the RH drops below 50%. If RH lowers to 60% there already is a reduction in mucociliary frequency of 30% (Mercke & Toremalm, 1976b; Mercke, 1975a). During normal nasal breathing, the inhaled air is also filtered. This filtration is important because the spread of viral and bacterial disease by way of the atmosphere requires, among other things, that infectious particles be inhaled by susceptible individuals and deposited at effective sites within the respiratory system for the initiation of disease (Hatch, 1961). The filtration of air is a complicated subject and depends for example on tidal volume, breathing frequency, air flow velocity, and diameter of particle size (Hatch, 1961; Heyder & Rudolf, 1975). In laryngectomees, the filtration function of the upper airways is lost entirely due to tracheostomal breathing.
The loss of the nasal functions leads to a wide range of pulmonary complaints such as coughing, excessive sputum production, crusting, and shortness of breath (Harris & Jonson, 1974; Natvig, 1984; Todisco, Maurizi, Paludetti, Dottorini, & Merante, 1984; Togawa, Konno, & Hoshino, 1980; Torjussen, 1968; Usui, 1979; Hilgers, Ackerstaff, Aaronson, Schouwenburg, & Van Zandwijk, 1990). A large number of patients (54%) complain of increased chest infections (Jay, Ruddy, & Cullen, 1991), which is most probably due to the loss of the nasal functions as well. Extensive post-laryngectomy histological changes (squamous metaplasia of the respiratory ciliary epithelium and chronic inflammatory changes of the lamina propria) have been observed in the trachea at the level of the carina (Griffith & Friedberg, 1964; Roessler, Grossenbacher, & Walt, 1988). The pulmonary symptoms develop and increase during the first 6 to 12 months after the total laryngectomy and then tend to stabilize (Ackerstaff, Hilgers, Balm, & Van Zandwijk, 1995; Harris et al., 1974).
Laryngectomized patients experience the physical consequences of having a stoma (frequent sputum and phlegm production form the stoma and its interference with social activities) as the most severe side effect of their surgery (Mohide, Archibald, Tew, Young, & Haines, 1992). The respiratory symptoms significantly affect the quality of life of the patient: correlations were found between the respiratory symptoms and perceived quality of voice, aspects of daily life, anxiety and depression (Hilgers et al., 1990).
Benefits of HME use
In 1960, Toremalm (Toremalm, 1960) described the benefits of HME use for post-tracheotomy care: in comparison to nasal breathing, a person breathing through a tracheostoma loses about 500 ml of water. By using an HME it is possible to retain 250 to 300 ml of this water loss in the respiratory system (Toremalm, 1960). In the early seventies, the use of Heat and Moisture Exchangers for condition of the inhaled air during anaesthesia is described (Shanks & Sara, 1973; Steward, 1976). In 1990, Ackerstaff and colleagues were the first to publish results on the use of an HME in laryngectomized patients (article in Dutch: Ackerstaff, Hilgers, Aaronson, Schouwenburg, & van Zandwijk, 1990). They studied the influence of an HME on respiratory symptoms in 42 laryngectomized patients. The HME (Stomvent) was found to significantly reduce sputum production, reduce forced expectoration in order to clear the airways, and reduced stoma cleaning after using the device for 6 weeks (Hilgers, Aaronson, Ackerstaff, Schouwenburg, & van Zandwijk, 1991). This reduction in respiratory symptoms led to an improvement in quality of life; symptoms of fatigue and malaise decreased significantly and social contacts improved (Hilgers et al., 1991). Patients using a voice prosthesis benefited less from the device used in this study than patients using esophageal or artificial larynx speech since they experienced difficulties in occluding the device for speaking (Hilgers et al., 1991). The HME and baseplate tested in this study could not be separated which led to a relatively large number of problems with loosening of the adhesive due to coughing (Hilgers et al., 1991). Also, with this kind of HME the device will always need to be removed for stoma and prosthesis cleaning.
In a later study a device was tested in which the HME and baseplate could be separated (Freevent) (Ackerstaff, Hilgers, Aaronson, Balm, & van Zandwijk, 1993). Patients were randomized into a treatment (n=24) and control (n=24) group and additionally 15 patients that participated in the previous study were included to compare the two devices. The results of this study showed that the HME user group showed significant reductions in the incidence of coughing, the mean daily frequency of sputum production, forced expectoration, and stoma cleaning. Also significant improvements were found in shortness of breath, fatigue and malaise, sleeping problems, anxiety, depression, and perceived voice quality. Pulmonary function tests showed significant improvements in inspiratory flow and volume values following the use of an HME. Despite the fact that the HME and base plate could be separated, loosening as a result of coughing still occurred frequently because the stoma was still not accessible for cleaning due to two crossed plastic bars blocking the entrance. Also, this device was still difficult to occlude for tracheoesophageal speech. In a multi-centre study in the Netherlands (Ackerstaff et al., 1995) the same HME (Freevent) was tested in 59 new patients that were enrolled in the study after postoperative or postradiotherapy wound healing was complete. Patients were interviewed at 3 months and 6 months of using the HME. The results of this study showed that significant improvements over time were found for forced expectoration, perceived voice quality, social anxiety, social interactions, and in feelings of anxiety and depression.
In a study by Keck et al. (Keck et al., 2005) it was shown that the tracheal climate rapidly changed after application and removal of an HME. The use of an HME increased the temperature from 27-28oC to 29-30oC and increased the RH from 50% to 70% (Keck et al., 2005).
Jones et al (Jones et al., 2003) compared pulmonary complaints between HME-users and a placebo group. Their results showed that the subjective respiratory parameters coughing, number of chest infections, mucus production and shortness of breath at rest were all improved in the HME group.
It is not expected that an HME compensates for the loss of upper airway filtration; the pores of the HME filter are larger than the diameter of the infectious particles. Only larger particles are filtered by the HME.
Provox HME
The Provox HME was developed to address the issues with the early HMEs: decreased compliance due to difficulties with adherence of the base plate and troublesome combination with a voice prosthesis. Development was guided by the remarks from patients in the two previous studies. The Provox HME consists of a separate HME cassette and a self-adhesive baseplate available in two different shapes and three different materials to accommodate different skin types in stoma shapes. The HME has a spring type valve that can easily be occluded by finger for tracheoesophageal speech. The air openings are at the side of the HME such that possible occlusion by clothes or sheets is avoided. Removal and insertion of the HME from and into the base plate is easy and after removal the patient has open access to the stoma to clan the area and the voice prosthesis.
In a first study (Hilgers, Ackerstaff, Balm, & Gregor, 1996) the feasibility of the device was investigated in 19 patients. The results showed that all patients were positive about the valve closure mechanism. They reported that voicing was considerably facilitated and intelligibility improved. Also, the problems with loosening of the baseplate due to phlegm were much decreased.
In a long-term compliance study of the Provox HME in 69 patients (Ackerstaff, Hilgers, Balm, & Tan, 1998), 63% of the patients reported that voicing was facilitated, 55% reported that their intelligibility had improved, 65% reported that respiratory symptoms had diminished, 94% reported a considerable overall benefit of the device, 78% of the patient used the device on a regular daily basis, 6% used it irregularly and 16% did not use the device. There was an obvious relationship between the length of use of the device and pulmonary complaints. The longer the device was used, the more the pulmonary complaints (coughing, forced expectoration, sputum production) decreased.
These results are confirmed by similar studies in Spain (article in Spanish: Herranz Gonzalez-Botas, Suarez, Garcia Carreira, & Martinez Moran, 2001) and a study in the US (Ackerstaff et al., 2003), indicating that results can be expected to be similar across cultures and climates. For example, the study performed in the US (Ackerstaff et al., 2003) showed that compliance was 73%, 68% of the patients reported a decrease in coughing, 73% reported decreased sputum production, 60% reported decreased forced expectoration, and 52% reported decreased need for stoma cleaning. The daily cough-expectoration frequency decreased significantly. In this study, the patients also reported improvements in voice quality, pitch, loudness, and intelligibility.
A study comparing finger occlusion directly on the stoma and finger occlusion on top of the Provox HME (within patient comparison) has demonstrated that maximum phonation time and dynamic loudness range improved in the condition where the patient was occluding on top of the HME (Van As, Hilgers, Koopmans-van Beinum, & Ackerstaff, 1998). This can probably be attributed to better, airtight, occlusion and better distribution of occlusal forces (reducing force on the voice prosthesis and voice producing segment in the esophagus).
Provox Freehands HME
In addition the Provox HME that requires finger occlusion, also a device has been developed that enables hands-free speech: The Provox Freehands HME. This device combines and HME with an automatic speaking valve. Upon increased exhalation required for speaking, the membrane in the valve part of the device closes off automatically, enabling the pulmonary air to be diverted through the voice prosthesis into the esophagus. This device is developed specifically for prosthetic tracheoesophageal speakers. The unique features of this device are the combination of an HME and hands-free valve (valve cannot be used without the HME), an adjustable cough relief valve that allows the air that is build up during coughing to escape, an on-off position that allows the patient to switch of the speech valve function when closing of the valve is not desired, and the availability of the speech membranes in three different strengths to accommodate different speaking pressures.
In a first study (Hilgers et al., 2003), the feasibility of this device was investigated in 20 laryngectomized speakers of whom 5 already used an existing automatic speaking valve. Five patients discontinued using the device during the study due to problems with adherence of the base plate to the skin. Of the remaining 15 patients, 11 users used the device on a regular daily basis. The study showed that maximum phonation time and dynamic loudness range using the Provox Freehands HME were lower than with a regular Provox HME, but higher than with another hands-free device. The finding that the use of hands-free devices results in less good phonation times can be attributed to the fact that when using a hands-free device some of the speaking air is consumed for closing the valve mechanism. The finding that the dynamic loudness range is smaller can be attributed to the fact that more air pressure is required to close the valve.
In a subsequent multi-center study (Op de Coul et al., 2005), compliance, quality of life, and voice quality aspects of the Provox Freehands HME were studies in 79 laryngectomized patients. Eight of them were regular users of another hands-free device, 58 had used another hands-free device unsuccessful, and 13 had never used a hands-free device. After a trial period of 6 months, 19% of the patients used the device on a daily basis (average of 5 hours), 57% used it irregularly, for example at special occasions of for a limited number of hours per day. Maximum phonation time and dynamic loudness range were found to be better than with another automatic peaking valve, but worse than with the regular Provox HME.
Tervonen et al. (2005) compared the Provox Freehands HME with the regular Provox HME in 14 patients and also found that speaking characteristics were less good when using an automatic speaking valve. Compared to the Provox HME that is occluded by finger, speaking with the Freehands HME was more difficult in 50% and easier in 21%; breathing was heavier in 64% and easier in 14%; and subjective voice quality was worse in 29% and better in 21%. Despite its limitations, 13 out of the 14 patients continued to use the device; one of them continuously and 12 of them occasionally. The one patient that discontinued its use had difficulties with the adhesive. During this study the XtraBase adhesive was tested that was developed especially for hands-free speech. The base of this adhesive is more rigid and gives more support to the peristomal area. Both when used with a regular HME and with the Freehands HME, on average the patients rated the skin adherence of the XtraBase as better than that of the ‘conventional’ (Optiderm, Regular, Flexiderm) adhesives.
Hamade et al. (2006) performed perceptual and acoustic analysis to compare speech with manual stoma occlusion and with the Provox Freehands HME in four patients. The objective analyses showed that maximum phonation time, intensity of read speech, and percentage pause time were all significantly decreased when using the automatic speaking valve and that random noise in the speech signal increased and extraneous noise caused by the valve increased when using the hands-free device. These results were not confirmed by the perceptual evaluations. Data from a questionnaire and patient diary suggested that the main advantage of the device is the ability to speak hands-free when performing a manual task, the main disadvantage was problems with base plate seal.
HME and filtration
There are currently some devices on the market that are used in ventilator dependent patients and during anesthesia that have both Heat and Moisture Exchanging and Filtration capacities (HUMIDVENT, Gibeck; HMEF, GE Healthcare). The use of and HME with Filter has been found to decrease the incidence of Ventilator Associated Pneumonias (VAPs) in ventilated patients on the intensive care unit (ICU) in comparison with Heated Hunidifiers ((Kirton et al., 1997; Kranabetter et al., 2004)). A review in 1988 by Subayi et al. (Subayi et al., 1998) showed that HMEFs decrease the rate of nosocomial pneumonias in comparison with heated humidifiers. In a study that was carried out in guinea pigs, a bacterial and viral filter was found to successfully protect the pigs from sensitization to aerosolized Natural Rubber Latex (Barbara et al., 2005). Also, the use of HMEFs during anesthesia prevents bacterial migration from the patient to anesthesia circle systems (Boots et al., 1997; Rathgeber et al., 1997).
Attachement of HME, Freehands HME and Provox Micron HME
The HME devices can be attached to the tracheostoma in two different ways: peristomally (base plate) or intraluminally (laryngectomy tube or stoma button).
For peristomal attachment the Provox HME can be attached into a variety of available Provox adhesives (Provox Optiderm, Regular, Flexiderm, or XtraBase). Additionally, some patients may require the use of Provox Silicone Glue to improve the seal of the adhesive to the skin. Other products that are required for proper application of the adhesive are Remove (to remove glue from the skin) and SkinPrep (to protect the skin against adhesive and glue and prevent skin irritation).
For intraluminal attachment the HME device can be attached into a LaryTube or a LaryButton. The primary goal of using a LaryTube or LaryButton is usually to maintain stoma patency, although more recently a LaryButton has also shown to be beneficial in combination with a hands-free speaking valve.
The Provox LaryTube is a so-called laryngectomy tube or tracheostoma tube. Many laryngectomized patients require a laryngectomy tube to maintain stoma patency, especially in the early postsurgical days and during postoperative radiotherapy (Ward, Acton, & Morton, 2006). Some patients experience permanent problems with stoma patency, requiring permanent use of a laryngectomy tube (Ward et al., 2006). The unique feature of the Provox LaryTube is that it is the only laryngectomy tube available that holds an HME. The LaryTube can hold a Provox HME or Provox Freehands HME. The LaryTube is held in place with a tubeholder (necktie) or it can be clicked into a baseplate (model with Blue Ring). For patients using a voice prosthesis, a fenestrated LaryTube is available. Laryngectomy tubes are considered a necessary part of laryngectomy care. A stoma that is too small causes difficulties in breathing and changing the voice prosthesis. There are no studies available on LaryTube or laryngectomy tubes in general.
The Provox LaryButton is a so-called laryngectomy button or stoma button. A stoma button is primarily used in stoma’s that are shrinking and that have a tight ‘lip’ or ‘rim’ that holds the button in place (Ward et al., 2006). The LaryButton holds and HME or Freehands HME. Studies have shown that the use of a stoma button increases successful use of a hands-free speaking valve (Lewin et al., 2000). The unique features of the LaryTube are that it, in contrast to other available models, is more stoma and patient friendly in design (rounder edges, softer materials) and that it can be held in place by using an additional neck tie or LaryClips (small adhesives combined with Velcro-attached hooks). These additional features enlarge the number of patients that is able to use the device. The need for a tight ‘lip’ or ‘rim’ to hold the button in place is less important. The LaryButton and LaryClips were only recently developed and a study that is still in press (Hilgers & Ackerstaff, 2006) demonstrated that the system was appreciated by the majority of the patients and that its use led to increased usage of hands free speaking valves.