RT Journal Article SR Electronic T1 Patient-specific tracheal stoma plug improves quality of life for tracheostomy patients JF BMJ Innovations JO BMJ Innov FD All India Institute of Medical Sciences SP bmjinnov-2022-001028 DO 10.1136/bmjinnov-2022-001028 A1 Kyle K VanKoevering A1 Julia Brennen A1 Rachel Fenberg A1 Sam Dolphin A1 Natalia von Windheim A1 Laura Matrka A1 Brad de Silva A1 Matthew E Spector A1 Steven B Chinn A1 Philip Choi A1 Songzhu Zhao A1 Keith A Casper A1 Glenn E Green YR 2022 UL http://innovations.bmj.com/content/early/2022/12/05/bmjinnov-2022-001028.abstract AB 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.