A multicenter randomized crossover study of a new peristomal adhesive and Heat and Moisture Exchanger (HME) for nighttime pulmonary rehabilitation in laryngectomized patients.

A multicenter randomized crossover study of a new peristomal adhesive and Heat and Moisture Exchanger (HME) for nighttime pulmonary rehabilitation in laryngectomized patients. - A new nighttime peristomal adhesive and HME

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43200

Enrollment

Registered

2016-12-16

Start date

2017-01-15

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

laryngectomy removal of larynx

Interventions

Use of Provox Luna during the night for four weeks. The patient is instructed to use the system every night. In case of irritation due to removal of the daytime adhesive, this can be adjusted in con

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Total laryngectomy, with or without any further pharyngeal or esophageal reconstructions 18 years or older HME user Adhesive user Longer than 3 months after total laryngectomy Longer than 6 weeks after postoperative radiotherapy

Exclusion criteria

Exclusion criteria: Medical problems prohibiting the use of an HME or adhesive Active recurrent or metastatic disease (medical deterioration) Reduced mobility of arms and/or hands, unable to remove an HME Unable to understand the Patient Information and/or unable to give Informed Consent Insufficient cognitive ability to handle the HME or adhesive Use of cannula (eg LaryTube) during day or night on medical description

Design outcomes

Secondary

Measure	Time frame
* Hours HME use per day and days per study period * Reasons for non-compliant HME use (device related or non-device related) * Performance and pulmonary effects of Provox Luna HME measured by structured study specific questionnaires * Performance and skin effects of Provox Luna Adhesive measured by structured study specific questionnaires * Patient satisfaction with various aspects of the Provox Luna system using study specific structured questionnaires * Sleeping, as a psychosocial aspect related to pulmonary rehabilitation, by using study specific structured questionnaires * General Quality of Life measured using EQ-5D	—

Measure

Time frame

* Hours HME use per day and days per study period * Reasons for non-compliant HME use (device related or non-device related) * Performance and pulmonary effects of Provox Luna HME measured by structured study specific questionnaires * Performance and skin effects of Provox Luna Adhesive measured by structured study specific questionnaires * Patient satisfaction with various aspects of the Provox Luna system using study specific structured questionnaires * Sleeping, as a psychosocial aspect related to pulmonary rehabilitation, by using study specific structured questionnaires * General Quality of Life measured using EQ-5D

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Primary

Measure	Time frame
The primary outcome measure of this study is compliance of HME use. Compliant HME use is a surrogate endpoint for pulmonary rehabilitation in laryngectomized patients. Compliant use is defined as at least 20 hours per day, 86% of the time. Compliance will be measured as the hours use per day and night for a 4-week period, by means of a diary, and finally a patient will be defined as compliant or non-compliant. When non-compliance is not related to the use of medical devices, this will not be analyzed as non-compliant. Compliance in the Provox Luna period will be compared with compliance in the usual care period.	—

Measure

Time frame

The primary outcome measure of this study is compliance of HME use. Compliant HME use is a surrogate endpoint for pulmonary rehabilitation in laryngectomized patients. Compliant use is defined as at least 20 hours per day, 86% of the time. Compliance will be measured as the hours use per day and night for a 4-week period, by means of a diary, and finally a patient will be defined as compliant or non-compliant. When non-compliance is not related to the use of medical devices, this will not be analyzed as non-compliant. Compliance in the Provox Luna period will be compared with compliance in the usual care period.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)