Medical Devices: Evidence and Research (Jul 2023)

Extracorporeal Artificial Lungs: Co-Creating Future Technology – A Qualitative Analysis

  • Dormann J,
  • Wendt S,
  • Dreher M,
  • Ansems K,
  • Rolland C,
  • Spillner J,
  • Szafran A,
  • Breuer T,
  • Pison C,
  • Verbelen T,
  • Benstoem C

Journal volume & issue
Vol. Volume 16
pp. 201 – 210

Abstract

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Julia Dormann,1 Sebastian Wendt,1 Michael Dreher,2 Kelly Ansems,1 Carole Rolland,3 Jan Spillner,4 Agnieszka Szafran,1 Thomas Breuer,1 Christophe Pison,5– 7,* Tom Verbelen,8,* Carina Benstoem1,* 1Department of Intensive Care Medicine and Intermediate Care, Medical Faculty, RWTH Aachen University, Aachen, Germany; 2Department of Pneumology and Intensive Care Medicine, RWTH Aachen University, Aachen, Germany; 3Techniques de l’Ingénierie Médicale et de la Complexité (TIMC), Centre National de la Recherche Scientifique (CNRS), University Grenoble Alpes, Grenoble, France; 4Department of Thoracic Surgery, Medical Faculty, RWTH Aachen University, Aachen, Germany; 5Department of Pneumology and Physiology, CHU Grenoble Alpes; University Grenoble Alpes, Grenoble, France; 6Laboratory of Fundamental and Applied Bioenergetics, LBFA, Inserm1055, Grenoble, France; 7Département Universitaire des Patients Grenoble Alpes, University Grenoble Alpes, Grenoble, France; 8Department of Cardiovascular Sciences, KU Leuven and Department of Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium*These authors contributed equally to this workCorrespondence: Carina Benstoem, Department of Intensive Care Medicine and Intermediate Care, Medical Faculty, RWTH Aachen University, Pauwelsstr. 30, Aachen, D-52074, Tel +49 241 80 38038, Fax +49 241 80 33 82182, Email [email protected]: Terminal lung diseases such as chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH) in progression cause a large reduction in quality of life and may lead to bilateral lung transplantation (bLTx). An artificial portable lung could provide a bridge to lung transplantation, allowing patients to remain at home and mobile for longer. To advance the development of such an artificial lung, patient feedback is essential. The aim of this study is to analyze patient acceptance about an extracorporeal artificial lung and to implement these findings into the development.Methods: In collaboration with a medical device developer, we presented a portable dummy oxygenator to patients with advanced lung disease, as potential end users. Data collection in Germany and France was based on two different methods: an online questionnaire and face-to-face interviews (F2F).Results: A total of 604 participants answered the online questionnaire and 17 participants were included in the F2F interviews. The majority of participants (COPD n=140, PH n=17) were able to walk more than 1 km with a mean suffering pressure of 2.87 and 3, respectively. Six of the 17 F2F participants who could walk < 1 km were interested in an assistive device. The statistical value of Fisher’s exact test for suffering pressure and desire for a portable oxygenator was 0.45.Conclusion: In patients with advanced lung disease, there is no statistically significant association between subjectively increased suffering pressure and desire for a portable oxygenator, so market introduction may be difficult. Potential end users should be implemented early in device development. Data collection via an online questionnaire combined with personal interviews has proven to be a successful approach here.Keywords: chronic obstructive pulmonary disease, pulmonary hypertension, artificial lung, patient feedback

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