Assessment of the New Provox Life System for Pulmonary Health and Quality of Life After Total Laryngectomy

Atos Medical

Status: Completed

Conditions: Laryngectomy

Treatments: Device: Usual Care; Device: Provox Life

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04974801

Prot_Id_3523

Details and patient eligibility

About

Background: The benefits of using Heat and Moisture Exchangers (HMEs) for pulmonary rehabilitation after total laryngectomy are widely known. However, current available HMEs do not reach the level of humidification capacity of the nose, and patients adherence to using an HME 24/7 is not always possible. Provox Life HMEs and attachments are a new range of HMEs and attachments, with improved humidification/breathability performance, and designed to suit different situations.

Purpose and aim: In this clinical trial, the new Provox Life System was assessed for pulmonary rehabilitation and QoL after total laryngectomy, and compared with currently available HMEs and attachments.

Methods: Forty laryngectomized patients, who were previous users of HMEs, were randomized to Usual Care or Provox Life for 6 weeks, after which a cross-over occurred. Data was collected at baseline, and after the end of each study period. Additionally, patients filled in a diary and tally sheet to record their forced expectorations and coughing.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Total laryngectomy, irrespective of pharynx reconstruction method
• 18 years or older
• Provox XtraHME user
• Provox Adhesive user
• Longer than 3 months after total laryngectomy
• Longer than 6 weeks after postoperative radiotherapy

Exclusion criteria

• Medical problems prohibiting the use of HME or adhesive
• Active recurrent or metastatic disease (medical deterioration)
• Recent pulmonary infections/unstable pulmonary condition
• 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
• LaryButton users

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Provox Life HMEs followed by Usual Care HMEs

Other group

Description:

Use of Provox Life devices during a period of six weeks followed by use of Usual Care devices during a period of six weeks.

Treatment:

Device: Provox Life

Device: Usual Care

Usual Care HMEs followed by Provox Life HMEs

Other group

Description:

Use of Usual Care devices during a period of six weeks followed by use of Provox Life devices during a period of six weeks.

Treatment:

Device: Provox Life

Device: Usual Care