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Medical devices
Patient-specific tracheal stoma plug improves quality of life for tracheostomy patients
  1. Kyle K VanKoevering1,2,3,
  2. Julia Brennen4,5,
  3. Rachel Fenberg1,6,
  4. Sam Dolphin2,
  5. Natalia von Windheim1,3,
  6. Laura Matrka1,
  7. Brad de Silva1,
  8. Matthew E Spector5,
  9. Steven B Chinn5,
  10. Philip Choi7,
  11. Songzhu Zhao8,
  12. Keith A Casper5,
  13. Glenn E Green5
  1. 1 Department of Otolaryngology- Head and Neck Surgery, The Ohio State University, Columbus, Ohio, USA
  2. 2 Department of Biomedical Engineering, University of Michigan College of Engineering, Ann Arbor, Michigan, USA
  3. 3 Center for Design and Manufacturing Excellence, The Ohio State University, Columbus, Ohio, USA
  4. 4 Department of Otolaryngology, Vanderbilt University, Nashville, Tennessee, USA
  5. 5 Department of Otolaryngology- Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA
  6. 6 Albert Einstein College of Medicine, Bronx, New York, USA
  7. 7 Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, USA
  8. 8 Department of Biomedical Informatics, The Ohio State University, Columbus, Ohio, USA
  1. Correspondence to Rachel Fenberg, Department of Otolaryngology- Head and Neck Surgery, Ohio State University, Columbus, OH 43210, USA; rachel.fenberg{at}osumc.edu

Abstract

Objective Despite being life-saving, tracheostomies carry numerous social, functional and quality of life (QOL) drawbacks. The aim of this study was to design and test the use of small, discrete, customised tracheostomy stoma plugs in patients who are not tracheostomy-dependent during the day, with the overall goals to demonstrate the feasibility of creating these patient-specific devices and obtain preliminary results of impact on QOL.

Methods We developed and evaluated a novel patient-specific ‘stoma plug’ to improve the lives of those with tracheostomies who did not have a daytime ventilation requirement. The stoma plug was designed and manufactured using three-dimensional printing for each subject. Measurements of the patient’s fistula were obtained in the clinic and the features of the stoma plug were created to match the fistula and trach tube dimensions. Patients were monitored for any changes in their eligibility status and for complications associated with using the ‘stoma plug’. A survey questionnaire examining multiple QOL domains was performed predevice and at 1 and 6 months of use.

Results Devices were designed and produced for 35 patients enrolled across two institutions. The survey results demonstrate statistically significant improvement in quality-of-life scores (p<0.05) in all six domains queried (Overall QOL, voice strength, voice clarity, water tolerance, swallowing and breathing) with substantial improvements in social isolation and skin irritation reported.

Conclusion Our study demonstrates that a patient specific device can be created to ameliorate many of the drawbacks associated with a tracheostomy tube, with the potential to revolutionise tracheostomy care.

  • quality of lIfe
  • otolaryngology
  • biomedical engineering
  • respiratory tract diseases

https://doi.org/10.1136/bmjinnov-2022-001028

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    Footnotes

    • Contributors KKVK created the novel device, served as PI on IRB approved studies for the device, and serves as the guarantor for this study. GEG aided in the creation of the novel device. KKVK, SD, RF, NvW and GEG helped with the production and manufacturing of these devices. KKVK, JB, LM, BdS, MES, SBC, PC, KAC and GEG provided and cared for study patients as well as recruited them for this study. SZ did statistical analysis on survey results. All authors critically reviewed the final manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests The trach plug has been submitted and awarded a provisional patent (US2020/0078548 A1). The device has not been licensed and is not commercially available. KKVK and GEG are cofounders in an unrelated 3D printing company that produces medical simulators. NVW has equity in an unrelated medical device company that produces orthopedic devices.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.