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

Laryngectomy Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Laryngectomy

Clinical Trial Details

NCT number	NCT04974801
Study type	Interventional
Source	Atos Medical AB
Contact
Status	Completed
Phase	N/A
Start date	December 14, 2020
Completion date	April 21, 2021

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT03269396` - Laryngeal Allograft Transplantation	N/A
Not yet recruiting	`NCT04268459` - Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.	N/A
Recruiting	`NCT05349487` - SpeakFree Heat and Moisture Exchanger (HME)	N/A
Completed	`NCT04943731` - Day/Night Regimen With Provox Life Heat and Moisture Exchangers	N/A
Completed	`NCT05079386` - Clinical Feasibility of a New Voice Prosthesis	N/A
Active, not recruiting	`NCT04100954` - Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy	N/A
Recruiting	`NCT02870556` - Effect of Cervical Epidural Analgesia on the Occurrence of Pharyngocutaneous Fistula	N/A