Evidence supporting Provox Life – Longobardi study
New randomized crossover study shows significant improvements in pulmonary symptoms for patients with total laryngectomy when switching to new product range. New clinical evidence from a prospective crossover study shows significant improvement in pulmonary symptoms for people living with a laryngectomy when switching to a new generation of devices, Provox Life.
Study objectives
The objectives of the clinical study were to evaluate the effects of the use of new devices (HMEs and adhesives) on pulmonary symptoms, adherence to HME use, quality of life, dermatological symptoms, and patient satisfaction in patients with a total laryngectomy. The study took place at the Catholic University of the Sacred Heart (Gemelli Hospital) in Rome, Italy. Between December 2020 and April 2021, 40 laryngectomized patients in Italy who routinely used HMEs and adhesives were enrolled.
Study outcomes
Patients were allocated into two different groups:
- Group A - 6 weeks use of the new Provox Life devices, followed by 6 weeks use of their usual devices
- Group B - 6 weeks use of their usual devices followed by 6 weeks use of the new Provox Life devices
In both groups, after six weeks of using the new devices, there was:
- A significant reduction in the daily forced expectorations and dry coughs
- A significant improvement in all domains of the Cough and Mucus Assessment questionnaire (CASA-Q)
- An increase in adherence to HME use
- A significant reduction in shortness of breath and skin irritation
- Significantly better scores in the anxiety/depression domain of the European Quality of Life Five Dimension instrument (EQ-5D)
The crossover study concludes:
“Achieving this reduction in patients who were already highly adherent to HME use is clinically relevant and underscores the importance of using better performing HMEs that can compensate for the humidification deficit. Improving pulmonary symptomatology could reduce patient restrictions in daily life and avoidance of social activity, with a consequent positive effect on Quality of Life.”
Atos Medical Vice President, Medical & Scientific Affairs, Corina van As-Brooks says: “We are so proud to see the difference our products make for people breathing through a neck stoma. Provox Life is setting a new standard of care.”
Journal
The article, “Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers”, is published in Otolaryngology–Head and Neck Surgery. It is the official peer-reviewed publication of the American Academy of Otolaryngology–Head and Neck Surgery Foundation.
The mission of Otolaryngology–Head and Neck Surgery is to publish contemporary, ethical, clinically relevant information in otolaryngology, head and neck surgery (ear, nose, throat, head, and neck disorders) that can be used by otolaryngologists, clinicians, scientists, and specialists to improve patient care and public health.
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CLINICAL SUMMARY
Download a clinical summary of the main findings of the study, “Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers”.
Provox Life is a new and improved range of products – designed to alleviate the challenges of excess mucus and coughing after undergoing a laryngectomy.
Reference:
Longobardi Y, Galli J, Di Cesare T, D’Alatri L, Settimi S, Mele D, Bussu F, Parrilla C. Optimizing Pulmonary Outcomes after Total Laryngectomy: Crossover study on new Heat and Moisture Exchangers. Otolaryngology Head Neck Surg. 2022.
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