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

NCT04974801 | Completed

• 1 other identifier: Prot_Id_3523
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pulmonary rehabilitation; Quality of Life; Heat and Moisture Exchangers

Outcome Measures

Primary Outcomes (1)

• Average number of forced mucus expectorations per 24 hours

  Patient reported, recorded by Tally sheeting on 3 days

  during week 6 of period 1 and period 2 (each period is 6 weeks)

Secondary Outcomes (12)

• Average number of (involuntary) dry coughs per 24 hours

  during week 6 of period 1 and period 2 (each period is 6 weeks)

• Coughing Symptoms (COUS) domain score of CASA-Q

  Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)

• Coughing Impact (COUI) domain score of CASA-Q

  Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)

• Sputum Symptoms (SPUS) domain score of CASA-Q

  Baseline, at the end of period 1, at the end of period 2 (each period is 6 weeks)

• Sputum Impact (SPUI) domain score of CASA-Q

  Baseline, at the end of Period 1, at the end of Period 2 (each period is 6 weeks)

Study Arms (2)

Provox Life HMEs followed by Usual Care HMEs

OTHER

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

Device: Provox Life; Device: Usual Care

Usual Care HMEs followed by Provox Life HMEs

OTHER

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

Device: Provox Life; Device: Usual Care

Interventions

Provox Life DEVICE

Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)

Provox Life HMEs followed by Usual Care HMEs; Usual Care HMEs followed by Provox Life HMEs

Usual Care DEVICE

Continued Usual Care routines.

Provox Life HMEs followed by Usual Care HMEs; Usual Care HMEs followed by Provox Life HMEs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atos Medical AB: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'

Roma, 00168, Italy

Location

Related Publications (1)

• Longobardi Y, Galli J, Di Cesare T, D'Alatri L, Settimi S, Mele D, Bussu F, Parrilla C. Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers. Otolaryngol Head Neck Surg. 2022 Dec;167(6):929-940. doi: 10.1177/01945998221086200. Epub 2022 Mar 22.

  PMID: 35316144 RESULT

Study Officials

• Claudio Parilla, Dr.

  Universita Cattolica del Sacro Cuore di Roma, Faculty of Medicine and Surgery 'Agostino Gemelli'

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, randomized, prospective crossover study

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 23, 2021
• Study Start: December 14, 2020
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)