Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects

Chathura B.B. Ratnayake; Renske Fles; I. Bing Tan; Laura W.J. Baijens; Walmari Pilz; Cees A. Meeuwis; Pauline H.E. Janssen-van Det; Rob van Son; Michiel W.M. Van den Brekel

doi:10.1002/lary.27839

Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects

Chathura B.B. Ratnayake, Renske Fles, I. Bing Tan, Laura W.J. Baijens, Walmari Pilz, Cees A. Meeuwis, Pauline H.E. Janssen-van Det, Rob van Son, Michiel W.M. Van den Brekel

Maxillofacial Surgery (AMC)

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Objectives: The aim of this study was to compare the relative compliance and the dermatological and pulmonary outcomes when the Provox Luna system (Atos Medical, Malmö, Sweden) is added during the night to the usual tracheastoma care of laryngectomized subjects. Methods: This was a multicenter randomized crossover trial conducted in the Netherlands Cancer Institute, Erasmus Medical Center, and Maastricht University Medical Center in The Netherlands. The study included 46 laryngectomized subjects with prior heat and moisture exchanger (HME) and adhesive experience. Results: A significant improvement in the number of compliant individuals was found: Luna: n = 43 of 45 (96%); usual care: n = 35 of 46 (76%), P = 0.02. The Luna period was associated with longer intervals of daily HME use (Luna 23.2 hours [range: 15.6–24.0 hours], usual care [UC]: 21.5 hours [range: 6.0–24.0 hours], P = 0.003) and an increased frequency of skin improvement overnight (Luna 3.9 days [standard deviation (SD)]: 7.0 days), Usual Care: 8.1 days ([SD: 10.8 days], P = 0.008). Fifty-six percent (n = 26) of participants wanted to continue using the Provox Luna system at the conclusion of the study. Conclusion: An improvement in compliance and skin recovery overnight was observed when the Provox Luna was added to the usual adhesive and HME use. Therefore, there is utility in supplementing the usual post-total laryngectomy care with the Provox Luna system at night, particularly in the setting of compliance concerns and in subjects who desire dermatological relief overnight. Level of Evidence: 1b. Laryngoscope, 129:2354–2360, 2019.

Original language	English
Pages (from-to)	2354-2360
Number of pages	7
Journal	The Laryngoscope
Volume	129
Issue number	10
DOIs	https://doi.org/10.1002/lary.27839
Publication status	Published - 1 Oct 2019

Bibliographical note

Funding Information:
The department of Head and Neck Surgery and Oncology of the Netherlands Cancer Institute receives a grant from Atos Medical AB to support their research in the field of rehabilitation of cancer patients.

Publisher Copyright:
© 2019 The Authors. The Laryngoscope published by Wiley Periodicals, Inc. on behalf of The American Laryngological, Rhinological and Otological Society, Inc.

Funding

The department of Head and Neck Surgery and Oncology of the Netherlands Cancer Institute receives a grant from Atos Medical AB to support their research in the field of rehabilitation of cancer patients.

Funders	Funder number
Atos Medical AB
Netherlands Cancer Institute

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1002/lary.27839

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@article{730b5274ea6c49a891c5569bc6187bb8,

title = "Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects",

abstract = "Objectives: The aim of this study was to compare the relative compliance and the dermatological and pulmonary outcomes when the Provox Luna system (Atos Medical, Malm{\"o}, Sweden) is added during the night to the usual tracheastoma care of laryngectomized subjects. Methods: This was a multicenter randomized crossover trial conducted in the Netherlands Cancer Institute, Erasmus Medical Center, and Maastricht University Medical Center in The Netherlands. The study included 46 laryngectomized subjects with prior heat and moisture exchanger (HME) and adhesive experience. Results: A significant improvement in the number of compliant individuals was found: Luna: n = 43 of 45 (96%); usual care: n = 35 of 46 (76%), P = 0.02. The Luna period was associated with longer intervals of daily HME use (Luna 23.2 hours [range: 15.6–24.0 hours], usual care [UC]: 21.5 hours [range: 6.0–24.0 hours], P = 0.003) and an increased frequency of skin improvement overnight (Luna 3.9 days [standard deviation (SD)]: 7.0 days), Usual Care: 8.1 days ([SD: 10.8 days], P = 0.008). Fifty-six percent (n = 26) of participants wanted to continue using the Provox Luna system at the conclusion of the study. Conclusion: An improvement in compliance and skin recovery overnight was observed when the Provox Luna was added to the usual adhesive and HME use. Therefore, there is utility in supplementing the usual post-total laryngectomy care with the Provox Luna system at night, particularly in the setting of compliance concerns and in subjects who desire dermatological relief overnight. Level of Evidence: 1b. Laryngoscope, 129:2354–2360, 2019.",

author = "Ratnayake, {Chathura B.B.} and Renske Fles and Tan, {I. Bing} and Baijens, {Laura W.J.} and Walmari Pilz and Meeuwis, {Cees A.} and {Janssen-van Det}, {Pauline H.E.} and {van Son}, Rob and {Van den Brekel}, {Michiel W.M.}",

note = "Funding Information: The department of Head and Neck Surgery and Oncology of the Netherlands Cancer Institute receives a grant from Atos Medical AB to support their research in the field of rehabilitation of cancer patients. Publisher Copyright: {\textcopyright} 2019 The Authors. The Laryngoscope published by Wiley Periodicals, Inc. on behalf of The American Laryngological, Rhinological and Otological Society, Inc.",

year = "2019",

month = oct,

day = "1",

doi = "10.1002/lary.27839",

language = "English",

volume = "129",

pages = "2354--2360",

journal = "The Laryngoscope",

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TY - JOUR

T1 - Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects

AU - Ratnayake, Chathura B.B.

AU - Fles, Renske

AU - Tan, I. Bing

AU - Baijens, Laura W.J.

AU - Pilz, Walmari

AU - Meeuwis, Cees A.

AU - Janssen-van Det, Pauline H.E.

AU - van Son, Rob

AU - Van den Brekel, Michiel W.M.

N1 - Funding Information: The department of Head and Neck Surgery and Oncology of the Netherlands Cancer Institute receives a grant from Atos Medical AB to support their research in the field of rehabilitation of cancer patients. Publisher Copyright: © 2019 The Authors. The Laryngoscope published by Wiley Periodicals, Inc. on behalf of The American Laryngological, Rhinological and Otological Society, Inc.

PY - 2019/10/1

Y1 - 2019/10/1

N2 - Objectives: The aim of this study was to compare the relative compliance and the dermatological and pulmonary outcomes when the Provox Luna system (Atos Medical, Malmö, Sweden) is added during the night to the usual tracheastoma care of laryngectomized subjects. Methods: This was a multicenter randomized crossover trial conducted in the Netherlands Cancer Institute, Erasmus Medical Center, and Maastricht University Medical Center in The Netherlands. The study included 46 laryngectomized subjects with prior heat and moisture exchanger (HME) and adhesive experience. Results: A significant improvement in the number of compliant individuals was found: Luna: n = 43 of 45 (96%); usual care: n = 35 of 46 (76%), P = 0.02. The Luna period was associated with longer intervals of daily HME use (Luna 23.2 hours [range: 15.6–24.0 hours], usual care [UC]: 21.5 hours [range: 6.0–24.0 hours], P = 0.003) and an increased frequency of skin improvement overnight (Luna 3.9 days [standard deviation (SD)]: 7.0 days), Usual Care: 8.1 days ([SD: 10.8 days], P = 0.008). Fifty-six percent (n = 26) of participants wanted to continue using the Provox Luna system at the conclusion of the study. Conclusion: An improvement in compliance and skin recovery overnight was observed when the Provox Luna was added to the usual adhesive and HME use. Therefore, there is utility in supplementing the usual post-total laryngectomy care with the Provox Luna system at night, particularly in the setting of compliance concerns and in subjects who desire dermatological relief overnight. Level of Evidence: 1b. Laryngoscope, 129:2354–2360, 2019.

AB - Objectives: The aim of this study was to compare the relative compliance and the dermatological and pulmonary outcomes when the Provox Luna system (Atos Medical, Malmö, Sweden) is added during the night to the usual tracheastoma care of laryngectomized subjects. Methods: This was a multicenter randomized crossover trial conducted in the Netherlands Cancer Institute, Erasmus Medical Center, and Maastricht University Medical Center in The Netherlands. The study included 46 laryngectomized subjects with prior heat and moisture exchanger (HME) and adhesive experience. Results: A significant improvement in the number of compliant individuals was found: Luna: n = 43 of 45 (96%); usual care: n = 35 of 46 (76%), P = 0.02. The Luna period was associated with longer intervals of daily HME use (Luna 23.2 hours [range: 15.6–24.0 hours], usual care [UC]: 21.5 hours [range: 6.0–24.0 hours], P = 0.003) and an increased frequency of skin improvement overnight (Luna 3.9 days [standard deviation (SD)]: 7.0 days), Usual Care: 8.1 days ([SD: 10.8 days], P = 0.008). Fifty-six percent (n = 26) of participants wanted to continue using the Provox Luna system at the conclusion of the study. Conclusion: An improvement in compliance and skin recovery overnight was observed when the Provox Luna was added to the usual adhesive and HME use. Therefore, there is utility in supplementing the usual post-total laryngectomy care with the Provox Luna system at night, particularly in the setting of compliance concerns and in subjects who desire dermatological relief overnight. Level of Evidence: 1b. Laryngoscope, 129:2354–2360, 2019.

U2 - 10.1002/lary.27839

DO - 10.1002/lary.27839

M3 - Article

C2 - 30786030

SN - 0023-852X

VL - 129

SP - 2354

EP - 2360

JO - The Laryngoscope

JF - The Laryngoscope

IS - 10

ER -

Multicenter randomized crossover trial evaluating the provox luna in laryngectomized subjects

Abstract

Bibliographical note

Funding

UN SDGs

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