Introduction
Total laryngectomy leads to an alteration of the normal physiology of the upper respiratory tract. Inspired air bypasses the upper airway because of the placement of a permanent tracheostoma, impeding physiological airway conditioning (warming, filtration and humidification).Reference Cole1 Total laryngectomy is associated with marked histological changes to the tracheal mucosa, including the loss of ciliated epithelial cells and goblet cell hyperplasia, which impairs mucociliary clearance.Reference Williams, Rankin, Smith, Galler and Seakins2,Reference Rosso, Prgomet, Marjanović, Pušeljić, Tićac and Mihaljević3
Heat and moisture exchangers are passive airway reconditioning devices that are positioned at the opening of the tracheostoma and improve tracheal climate, particle filtering and offer increased respiratory resistance.Reference Scheenstra, Muller, Vincent, Sinaasappel and Hilgers4 They retain heat and moisture in the core media, thereby warming and humidifying the inspired air and producing a beneficial effect on tracheal climate, pulmonary symptoms and related aspects.Reference Herranz, Espiño and Morado5 This series of benefits causes a reduction of coughing, forced expectoration, external humidifier use and healthcare costs.Reference Retèl, van den Boer, Steuten, Okła, Hilgers and van den Brekel6,Reference Zuur, Muller, de Jongh, van Zandwijk and Hilgers7
Obtaining these results is totally dependent on the time of use of the heat and moisture exchangers.Reference Ackerstaff, Hilgers, Balm and Tan8 Over time, technological advances have led to improvements in the design of this type of device, achieving greater adherence to its use.Reference Herranz, Espiño and Morado5 Despite this, there is room for improvement, as approximately 20 per cent of patients report skin irritation at the adhesive site and discomfort while sleeping with a heat and moisture exchanger device.Reference Hilgers, Dirven, Wouters, Jacobi, Marres and van den Brekel9 This is probably related to the inflexible synthetic materials of conventional heat and moisture exchangers as well as peristomal adhesives. With the intention of solving these kinds of problems, Atos Medical (Malmö, Sweden) has developed the Provox® LunaTM, which has a hydrogel-based soft adhesive and soft silicon housing designed for night use.Reference Provox10
The aim of this study was to assess individual preferences, symptoms and compliance between habitual use of Provox XtraFlow and the new combination of Provox XtraFlow during the day and Provox Luna during the night for heat and moisture exchanger therapy in laryngectomised patients.
Materials and methods
Trial design
An open, randomised, crossover trial was conducted, in which patients acted as their own control in order to limit bias and provide a valid control interval (Figure 1). This research involved human participants and was approved by the hospital's ethics committee. Informed consent was obtained from all individual participants included in the study.
Fig. 1. Study design diagram. HME = heat and moisture exchanger; TL = total laryngectomy; PPI = proton-pump inhibitors; XF = XtraFlow group; XF + PL = XtraFlow + Provox Luna group
After baseline data collection and a 15 day running-in period in which the participants had to use their usual heat and moisture exchangers with larytube but without adhesive, a simple randomisation in two groups was performed. Group A started using the XtraFlow heat and moisture exchanger and adhesive for 24 hours a day for 25 days (XtraFlow group). Group B started using a combination of the XtraFlow heat and moisture exchanger and adhesive for 12 hours a day and the Luna heat and moisture exchanger and adhesive for 12 hours at night for 25 days (XtraFlow + Provox Luna group).
After the first phase and a 5-day wash-out period, data were collected and treatment switching was performed for another 25 days. After the second phase and a five-day wash-out period, data were collected again (Figure 1). These rest periods were based on previous studies where the adhesive abandonment time was analysed and planned in order to rest the skin and reduce the possible effect of irritations or adverse reactions of previous adhesive and memory bias.Reference Ackerstaff, Fuller, Irvin, Maccracken, Gaziano and Stachowiak11 Patients were supplied with Luna and XtraFlow heat and moisture exchangers, Luna and regular adhesives, a shower cap and additional protective adhesive strips.
The assessment and follow up of patients was made by an otolaryngologist and a speech therapist every week during follow up to ensure they were recording daily observations and to solve any problem or adverse reaction. All patients were given a tally sheet and instructed to record daily heat and moisture exchanger use, type of heat and moisture exchanger or the alternative used during the night, the number of episodes of disrupted sleep because of coughing every night, the presence of skin irritation problems and psychosocial aspects.
Participants
Patients were recruited from the Department of the Otorhinolaryngology – Head and Neck Surgery Service of a tertiary university hospital. All laryngectomised patients being treated at the hospital are under prospective follow up in a database in which device changes and causes are collected.Reference Mayo-Yáñez, Cabo-Varela, Suanzes-Hernández, Calvo-Henríquez, Chiesa-Estomba and Herranz González-Botas12,Reference Mayo-Yáñez, Cabo-Varela, Dovalo-Carballo, Calvo-Henríquez, Martínez-Morán and Herranz González-Botas13
The inclusion criteria were: more than 18 years old, at least 3 months post-total laryngectomy, at least 3 months post-radiotherapy or chemotherapy where this type of treatment was given, being treated with proton-pump inhibitors and having had at least 3 months' experience with the Provox voice prosthesis, heat and moisture exchangers and adhesives.
Patients were excluded on the basis of prior medical problems preventing heat and moisture exchangers or adhesive use, recurrent or metastatic disease, use of another phonation method instead of the voice prosthesis, functional incapacity to insert and remove a heat and moisture exchanger or adhesive independently, inability to understand or provide informed consent, impaired cognitive ability, or regular use of any type of cannula.
Interventions
The Provox XtraFlow heat and moisture exchanger cassette (Figure 2a–c) is a single-use device that features a calcium chloride treated foam sponge in plastic housing, intended for patients breathing through a tracheostoma. It is a heat and moisture exchanger that heats and humidifies inhaled air by retaining heat and moisture from exhaled air in the device. It partially restores lost breathing resistance. Provox FlexiDerm Adhesive (Figure 2a) is a disposable device intended to hold Provox heat and moisture exchanger cassettes in front of the tracheostoma, as well as guaranteeing the airtightness of said cassettes. The Provox Luna System (Figure 2d–f) is a single use heat and moisture exchanger and adhesive for night-time that is designed to improve comfort and skin and lung health. Its adhesive base is a skin-friendly hydrogel intended for comfort and skin rest.
Fig. 2. Images of the heat and moisture exchanger systems that were evaluated. The images show: (a) XtraFlow heat and moisture exchanger system and Provox FlexiDerm Adhesive, (b) front view of the XtraFlow heat and moisture exchanger calcium chloride treated foam sponge cassette, (c) side view of the XtraFlow heat and moisture exchanger calcium chloride treated foam sponge cassette, (d) Provox Luna heat and moisture exchanger, (e) front view of the Provox Luna system cassette, and (f) side view of the Provox Luna system cassette.
Outcomes
The primary outcome measure in this study was the subjective comparison and preference of heat and moisture exchanger therapies. Secondary outcomes included objective comparison of heat and moisture exchanger therapies, pulmonary and dermatological effects, sleep, and psychosocial aspects, based on previous structured questionnairesReference Ackerstaff, Hilgers, Aaronson, De Boer, Meeuwis and Knegt14,Reference Leemans, Sluis, Son and Brekel15 through dichotomous or categorical responses with a single possible option according to the Likert methodology and the EuroQol five-dimensions instruments.16
Sample size
Sample size was calculated based on a statistical model for a binary outcome in a crossover group superiority trial.17 We determined that 28 patients per group were required to have an 80 per cent chance of detecting (as significant at the 5 per cent level) an increase in the primary outcome measure from 78 per cent in the control group to 100 per cent in the experimental group. These reference values were taken from previous studies of adherence to heat and moisture exchanger therapy.Reference Herranz, Espiño and Morado5,Reference Macri, Bogaardt and Parrilla18,Reference Pedemonte-Sarrias, Villatoro-Sologaistoa, Ale-Inostroza, López-Vilas, León-Vintró and Quer-Agustí19
Statistical analysis
The statistical analysis was performed sequentially: phase 1, baseline data description; phase 2, description of each treatment modality independently; phase 3, inference between XtraFlow treatment and XtraFlow plus Provox Luna treatment; phase 4, inference between treatment groups (group A versus group B) according to the order of administration.
Analysis was performed with SPSS® statistical software (version 24.0) where the tests were 2 tailed with a 95 per cent confidence interval. Incomplete responses were excluded from analysis. Normality was evaluated by the Kolmogorov–Smirnov test and variances were evaluated using the Levene test. Qualitative variables were expressed as frequency and percentage. The differences between groups were evaluated by the chi-square test, Fisher's exact test or its variants as appropriate.
Results
Patient description
A total of 28 patients were enrolled in the study (Table 1), with 26 men (92.86 per cent) and 2 women (7.14 per cent). The mean age was 63.54 ± 9.44 years. Regarding complementary treatment, 15 (53.6 per cent) did not require any, 8 (28.6 per cent) received radiotherapy (RT), 2 (7.1 per cent) received chemotherapy and 3 (10.7 per cent) received RT-chemotherapy. With the randomisation, 14 patients were included in group A and 14 in group B. The mean age of group A was 61.07 ± 7.63 years, and for group B was 66 ± 10.67 years (p = 0.393). There were no differences in the distribution of gender, RT or chemotherapy. No dropouts were collected and compliance with data collection in the diary was 100 per cent. The results of the different outcomes are summarised in Table 2.
Table 1. Baseline data
RT = radiotherapy; SD = standard deviation
Table 2. Outcomes
*Statistically significant data
Primary outcome
At the final evaluation, all 28 patients were asked about their overall patient experience comparing the Provox Luna system to the Provox XtraFlow (Table 3). Most of the patients (n = 17; 60.7 per cent) reported preferring Provox Luna therapy subjectively, and there were not statistically significant differences according to the order of treatment.
Table 3. Overall satisfaction between heat and moisture exchanger devices
XF = XtraFlow group; XF + PL = XtraFlow + Provox Luna group
Respiratory outcome
In patients with the XtraFlow, 10 (35.7 per cent) had no problems, and 18 (64.3 per cent) reported difficulty in passing air or dyspnoea using this type of filter. Of these 18, half reported difficulty at rest and half during physical effort. The need for forced expectoration or coughing spells was evaluated, finding that 12 (42.9 per cent) required doing it regularly: 6 (21.4 per cent) 1–2 times a day, 4 (14.3 per cent) 3–4 times a day and 2 (7.2 per cent) equal to or more than 5 times a day.
With the XtraFlow + Provox Luna treatment, the results in relation to difficulty in passing air or dyspnoea were identical: 10 patients (35.7 per cent) had no problems versus 18 (64.3 per cent) who did. Of these, 7 (25 per cent) reported it at rest and 11 (39.3 per cent) during physical effort (p = 0.502). The need for forced expectoration or coughing spells was mentioned by 12 (42.9 per cent) patients: 7 (25 per cent) did it 1–2 times a day, 4 (14.3 per cent) 3–4 times a day and 1 (3.6 per cent) equal to or more than 5 times a day.
According to the group of treatment (A vs B), there were no differences in the reporting of difficulty in passing air, although there was a higher frequency of dyspnoea during physical effort versus dyspnoea at rest in patients when they switched to using Provox Luna than vice versa (p = 0.003). There were no differences in the need for expectoration (p = 0.127) or its frequency (p = 0.165).
Dermatological outcome
According to the treatment modality, 24 (85.7 per cent) patients with XtraFlow required a daily cleaning of the stoma compared with 4 (14.3 per cent) who required it twice daily. Of the 28 volunteers, 13 (46.4 per cent) had dermatological problems (itching, irritation, inflammation or redness) compared with 15 (53.6 per cent) who did not. Of these 13 with problems, 5 (17.9 per cent) presented them every day, 5 (17.9 per cent) every week, 2 (7.1 per cent) at least once every 2 weeks, and 1 (3.6 per cent) at least once every 2 weeks or greater. All patients needed to stop the adhesives to improve: 7 (25 per cent) every night and 6 (21.4 per cent) on demand.
A total of 10.7 per cent (n = 3) of patients with XtraFlow + Provox Luna treatment required a daily cleaning of the stoma compared with 25 (89.3 per cent) who required two daily cleanings (p = 0.000). Four (14.3 per cent) had dermatological problems (itching, irritation, inflammation or redness) compared with 24 (85.7 per cent) who did not (p = 0.009). Of these 4 with problems, 2 (7.1 per cent) presented them every day, 1 (3.6 per cent) every week, and 1 (3.6 per cent) at least once every 2 weeks (p = 0.868). Of these, only 3 needed to stop the adhesives to improve (p = 0.003), 2 (7.1 per cent) every night and 1 (3.6 per cent) on demand.
Regarding the treatment group (A vs B), there were no differences in relation to the cleaning of the stoma (p = 0.098), the appearance of skin problems (p = 0.256) or their frequency (p = 0.414), or the need to stop the adhesives (p = 0.058).
Sleeping outcome
In the XtraFlow group, a total of 9 (32.1 per cent) patients routinely received hypnotic medication. Regarding the characteristics of sleep, 7 patients (25 per cent) reported difficulty falling asleep between 1 and 3 times a week. A total of 15 (53.6 per cent) reported difficulty in maintaining sleep, with either frequent nocturnal awakenings (n = 11; 39.3 per cent) or awakening every night (n = 3; 10.7 per cent). Despite these data, the majority of the patients reported that their sleep quality was good (n = 18; 64.3 per cent) or very good (n = 6; 21.4 per cent).
The same number of patients routinely received hypnotic medication in the XtraFlow + Provox Luna group. Difficulty falling asleep between 1 and 3 times a week was reported in 8 (28.6 per cent) patients (p = 0.763). A total of 14 (50 per cent) reported difficulty in maintaining sleep (p = 0.789), with frequent nocturnal awakenings (n = 12; 42.9 per cent) or awakening every night (n = 2; 7.1 per cent). The majority of the patients reported that their sleep quality was good (n = 19; 67.9 per cent) or very good (n = 6; 21.4 per cent) (p = 0.948).
According to the treatment group (A vs B), there were no differences in sleep conciliation (p = 0.385) or the frequency of this type of problem (p = 0.823). There were also no differences in presentation (p = 0.705) or frequency of awakenings, need for medication, or quality of sleep (p = 0.446).
Psychosocial outcome
All social interactions in the XtraFlow group were considered good (n = 23; 82.1 per cent) or acceptable (n = 5; 17.9 per cent). Attending specifically to the different emotions, 14 (50 per cent) patients reported being nervous, occasionally (n = 11; 39.3 per cent) or always (n = 3; 10.7 per cent), when interacting with other people. A total of 64.3 per cent (n = 18) reported concern, occasionally (n = 16; 57.1 per cent) or always (n = 2; 7.1 per cent). A total of 25 per cent (n = 7) irritability, occasionally (n = 6; 21.4 per cent) or always (n = 1; 3.6 per cent). And a total of 25 per cent (n = 7) reported sadness, occasionally (n = 4; 14.3 per cent) or always (n = 3; 10.7 per cent).
In the XtraFlow + Provox Luna group, 25 (89.3 per cent) participants considered social interactions to be good and 3 (10.7 per cent) as acceptable (p = 0.705). Attending specifically to the different emotions, 13 (46.4 per cent) patients reported being nervous (p = 0.789), either occasionally (n = 12; 42.9 per cent) or always (n = 1; 3.6 per cent) when interacting with other people (p = 0.596). A total of 60.7 per cent (n = 17) reported concern (p = 0.783), either occasionally (n = 16; 57.1 per cent) or always (n = 1; 3.6 per cent) (p = 0.226). A total of 25 per cent (n = 7) reported occasional irritability, and 21.4 per cent (n = 6) reported sadness (p = 0.752), either occasionally (n = 5; 17.9 per cent) or always (n = 1; 3.6 per cent) (p = 0.131).
Finally, the analysis according to the treatment group (A vs B) did not show differences in the quality of interactions (p = 0.326), in nervousness (p = 1.000) or their frequency (p = 0.192), in concern (p = 0.430) or its frequency (p = 0.477), in irritability (p = 1.000) or its frequency (p = 0.429), or in sadness (p = 1.000) or its frequency (p = 1.000).
Discussion
After total laryngectomy, the upper airway is permanently separated from the respiratory tract, and so no longer contributes to heating or cooling, moisturising and filtering of inspired air causing an increase in coughing, sputum production and frequent forced expectorations. A correlation between these consequences and perceived quality of voice, life and psychosocial aspects like anxiety or depression has been established.Reference Hilgers, Ackerstaff, Aaronson, Schouwenburg and Van Zandwijk20,Reference Mohide, Archibald, Tew, Young and Haines21
Numerous heat and moisture exchanger devices have been developed in order to compensate for the impairment of respiratory function of the upper aerodigestive tract (e.g. heating, cooling, filtering of air) and to improve quality of life of laryngectomised patients.Reference Herranz, Espiño and Morado5,Reference Ackerstaff, Fuller, Irvin, Maccracken, Gaziano and Stachowiak11,Reference Parrilla, Minni, Bogaardt, Macri, Battista and Roukos22 The aim of this open, randomised, crossover trial was to compare a new nocturnal heat and moisture exchanger (Provox Luna) with the standard heat and moisture exchanger therapy (Provox XtraFlow) by objective measurements (tally sheets) and subjective questionnaires.
Several studies comparing different models of heat and moisture exchangers have been published,Reference Herranz, Espiño and Morado5,Reference Hilgers, Dirven, Wouters, Jacobi, Marres and van den Brekel9,Reference Parrilla, Minni, Bogaardt, Macri, Battista and Roukos22 but there is only one study that analysed the new Provox Luna.Reference Ratnayake, Fles, Tan, Baijens, Pilz and Meeuwis23 The design of the present work is slightly different, considering the run-in and wash-out periods of the study, and because it only compared one type of heat and moisture exchanger (XtraFlow) with the Provox Luna in order to achieve a robust comparison and reduce the risk of bias. Owing to the randomised crossover trial design of the study, the patients were their own controls, thus allowing for meaningful comparison of compliance and preferences of the patients between the two periods. The demographic characteristics of the respondents (the distribution of age, sex, puncture, voice prosthesis, tumour–node–metastasis stage or surgery) were comparable to previous studies in the literature,Reference Herranz, Espiño and Morado5 and subsequent analysis according to randomisation showed no significant impact on all observable outcomes, suggesting that the study design was appropriate for the comparative assessment of heat and moisture exchanger use and results. Furthermore, long-term conclusions are difficult to draw from the short follow-up interval.
Analysis of the dataset showed a significant improvement in compliance and skin problems overnight during the Luna period, with this aspect being an important determinant of compliant heat and moisture exchanger use overnight. These data should be viewed with caution. Receiving weekly follow up and stressing compliance creates a situation with an artificially increased compliance. The compliance reported during the Provox Luna care period was 89.3 per cent, higher than previous reports in the literature and in the study by Ratnayake et al.Reference Ratnayake, Fles, Tan, Baijens, Pilz and Meeuwis23 Despite the fact that the non-use of heat and moisture exchanger devices during the night could cause a worsening of the quality of rest,Reference Herranz, Espiño and Morado5,Reference Ackerstaff, Hilgers, Aaronson, Balm and van Zandwijk24 no subjective or statistically significant differences were found in this aspect regarding treatment with the heat and moisture exchangers used or adherence to it. This may have resulted from the increased patient education with which the importance of heat and moisture exchanger use is stressed. It is true that a significant number of patients received hypnotic treatment on a regular basis, an aspect that could lead to bias and that it is necessary to evaluate in future studies with a longer follow up than the pre-requisite time for drug withdrawal.
• Currently, 20 per cent of patients report skin irritation at the adhesive site and discomfort when sleeping with a heat and moisture exchanger device
• The new Provox Luna for night-time uses a skin-friendly hydrogel base adhesive
• Using Provox Luna gives significant improvement in night compliance and skin problems
• A total of 60.7 per cent of the patients studied preferred to continue using the Provox Luna system
Taking into account the respiratory symptoms, our results suggest that coughing might reduce over time when the treatment was changed to the Luna heat and moisture exchanger and adhesive. These results are consistent with previous ones.Reference Ratnayake, Fles, Tan, Baijens, Pilz and Meeuwis23 The overall satisfaction of the patients was similar for the two types of treatment, and no statistically significant differences were demonstrated in the secretions, expectoration or dyspnoea. Where differences were seen was when switching from XtraFlow to XtraFlow + Provox Luna; this may be because of the new architecture of the Luna heat and moisture exchanger filter, with which the patients reported the need for a greater inspiratory effort at the beginning of its use. Despite this, pulmonary issues might be an underlying cause of many other issues, including experienced limitations in daily activities and avoidance of social activities. This aspect was also evaluated in our study. Most of the patients did not report problems in terms of their usual social interactions, or differences according to the type of heat and moisture exchanger used. These results are in line with previous studies in that the quality-of-life rating is mainly influenced by the ability to do meaningful activities as well as the age of the patient, and less by purely physical consequences of total laryngectomy.Reference Leemans, Sluis, Son and Brekel15,Reference Parrilla, Minni, Bogaardt, Macri, Battista and Roukos22
Conclusion
This open, randomised, crossover trial compared compliance, dermatological, pulmonary and psychosocial outcomes of adding the Provox Luna system for night-time use in laryngectomised patients. Significant improvements in night compliance and skin problems were observed with the Luna system. At the conclusion of the study, 17 (60.7 per cent) patients indicated they would continue using the Provox Luna system. The 39.3 per cent (n = 11) who indicated they did not want to continue mentioned that they perceived no advantages or that they disliked changing the adhesive more often or that it was more difficult for them to inhale air during use. Therefore, the Provox Luna system is a viable additive to heat and moisture exchanger therapy, especially in the setting of compliance concerns and in patients who desire dermatological relief overnight.
Competing interests
None declared
