NCT04974801

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

A Randomized Cross Over Clinical Trial Assessing the New Provox Life System for Pulmonary Rehabilitation and Quality of Life After Total Laryngectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Atos Medical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Laryngectomy

Interventions

Type	Name	Description
DEVICE	Provox Life	Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)
DEVICE	Usual Care	Continued Usual Care routines.

Timeline

• Start date: 2020-12-14
• Primary completion: 2021-04-21
• Completion: 2021-04-21
• First posted: 2021-07-23
• Last updated: 2022-04-05

Locations

1 site across 1 country: Italy