Abstract

Materials and Methods

The device was constructed using biocompatible polymeric material modeled by a 3‐dimensional printer (Figure 1) and is reusable and compatible with disinfectant solvents (alcohol‐based solvents such as isopropyl alcohol and 3% hydrogen peroxide). It consists of a hollow cylindrical body measuring 15cm in length (a), with 1 end featuring an ellipsoidal flare (b) for hermetic connection to a disposable mouthpiece or filter attached to a spirometer. The second end (c) is designed with a protrusion that adheres hermetically to a circular connector or adhesive patch placed on the tracheostoma. The adhesive patch is typically used by laryngectomized patients along with heat and moisture exchange (HME) filters for pulmonary rehabilitation. Additionally, the second end (c) includes an ellipsoidal anchoring flange (d) for securing a tracheostomy tube holder, ensuring further stability of the device during spirometry (Figure 2).

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Figure 1

(a) Cylindrical body; (b) hermetic connection to the mouthpiece; (c) connection end to the adhesive patch; (d) anchor flange for tracheostomy tube holder; (e) disposable mouthpiece for spirometer; (f) adhesive patch for heat and moisture exchange filter.

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Figure 2

(A) Ellipsoidal flare for hermetic connection to a disposable mouthpiece or filter attached to a spirometer. The second end (B) designed with a protrusion that adheres hermetically to a circular connector or adhesive patch placed on the tracheostoma.

The device was tested on 5 patients who underwent TL for laryngeal cancer, with an average age of 10±4.28 SD years postsurgery and no recurrence or second tumors. The patients were male ex‐smokers with an average history of 33±6 SD cigarettes per day, average age of 65.2±5.30 SD years, body mass index of 24.4±3.07 SD, average height of 172.8cm±54.5 SD, and average weight of 72.8kg±9.43 SD.

The study was approved by the Ethics Committee of the Calabria Region No. 111.

All patients provided informed consent. They were enrolled in our follow‐up program, and all had a diagnosis of chronic obstructive pulmonary disease before surgery.

The examination was performed with the patient in a seated position, securing the device distally to the spirometer filter and proximally to the HME filter adhesive patch. The device was further secured to the HME filter adhesive patch using a tracheostomy tube holder. We did not detect air leakage during lung function tests examination. Analyzing flow‐volume loops, we did not observe any evidence of leaks, cessation of airflow during the manoeuvre or inspirations during the trace. Acceptable manoeuvre quality was defined on the basis of American Thoracic Society (ATS)/European Respiratory Society (ERS) technical standard on interpretive strategies for routine lung function tests. The spirometry procedure followed conventional methods with satisfactory patient compliance (Figure 3). Spirometry and body plethysmography were performed using the MasterScreen pulmonary function testing system and MasterScreen Body (Jaeger‐Viasys; CareFusion), according to ATS/ERS guidelines.

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Figure 3

Application of the device.

The spirometric examination (Figure 4), conducted and reported by a specialist in pulmonology, identified mild obstructive ventilatory impairment in 2 patients, moderate in 2 patients, and severe in 1 patient.

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Figure 4

Spirometric examination: Evidence of respiratory function compatible with predominantly obstructive ventilatory impairment of moderate degree.

Discussion

TL involves the removal of the entire larynx, resulting in significant psychophysical and social consequences for the patient's quality of life. This is attributed to the immediate loss of phonation and alterations in respiratory and olfactory functions due to the permanent separation of the upper airways from the lower airways. The natural warming, humidification, and filtering of air that typically occur in the nasal cavities are lost when breathing through the stoma, thereby exposing the tracheobronchial tree to the risk of severe and debilitating inflammatory conditions.

Patients undergoing TL are mostly heavy smokers, and cigarette smoking is well‐known as one of the primary risk factors, along with alcohol and human papillomavirus infection, 2 for laryngeal carcinoma. Consequently, these patients often present with chronic pulmonary dysfunctions that require monitoring and treatment. Therefore, the possibility to perform spirometry becomes indispensable to ensure effective oncological follow‐up.

The device we have developed has proven to be airtight, robust, and reliable, allowing adaptation to all commercially available disposable filters. Thanks to its structural features, this device enables the patient to comfortably undergo the examination seated at an appropriate distance from the spirometry machine filter, ensuring airtight integrity with no air leaks during the spirometry. Based on these premises, the spirometric examination has demonstrated reliability and usefulness for diagnostic and therapeutic purposes.

Despite various methods reported in the literature for performing spirometry—such as placing the spirometer directly on the patient's stoma, 3 using plastic devices articulated to the tracheostoma, 4 adapting a tube connector, 4 or connecting the spirometer to the tracheostoma using a cardboard tube 5 —none of these devices have achieved standardized clinical application.

Conclusion

To date, there is no dedicated device for spirometry in total laryngectomized patients. Therefore, to evaluate lung function after TL, we have developed a simple and useful device that is easy to use and yields results comparable to conventional tests performed with a mouthpiece. From a physiological perspective, the use of our device aligns with the standardization and accuracy requirements of spirometry in patients who underwent TL.

Author Contributions

Maria Rita Bianco, analysis, and interpretation of data, authorship of the manuscript, final approval; Salvatore Andrea Pullano, design of the work, analysis and interpretation of data,final approval; Federico Occhiuzzi, design of the work, analysis and interpretation of data, authorship of the manuscript and interpretation of data; Daniele Latella, analysis, and interpretation of data, Marco Di Mieri, analysis, and interpretation of data; Corrado Pelaia, analysis, and interpretation of data; Eugenia Allegra, design of the work, analysis, and interpretation of data,authorship of the manuscript, final approval.

Disclosures

Funding source

None.

References