Use of TrachPhone in Tracheostomized Patients

NCT06487104 | Enrolling By Invitation

• 1 other identifier: TrachPhone
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The use of Heat and Moisture Exchangers (HMEs) and their positive impact on pulmonary health have been extensively studied in patients with head and neck cancer but have not been systematically explored in other patient populations breathing through a neck stoma. The objective of this clinical investigation is to compare the use of HMEs to the use of External Humidifiers (EHs) on pulmonary secretion management, their usability and safety, for humidifying inhaled air in patients that received a tracheostomy due to a neurological condition.

Conditions

Tracheostomy

Keywords

Heat and Moisture Exchangers; Secretion

Outcome Measures

Primary Outcomes (1)

• Number of suctioning per day

  Times per day suctioning is required

  At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)

Secondary Outcomes (13)

• Time needed for suctioning

  At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)

• Quality of secretion

  At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)

• Quality of Life by EQ-5D-5L

  At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)

• Use of TrachPhone

  At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)

• Patient preference

  Upon discharge from the hospital (on average after 3 weeks)

Study Arms (2)

Arm 1 - HME

EXPERIMENTAL

24/7 use of TrachPhone HME for the entirety of study

Device: TrachPhone HME

Arm 2 - EH

ACTIVE COMPARATOR

24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation.

Device: TrachPhone HME; Device: External Humidifier (Usual Care)

Interventions

TrachPhone HME DEVICE

Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients. The TrachPhone HME is an HME specifically designed for tracheostomy patients.

Arm 1 - HME; Arm 2 - EH

External Humidifier (Usual Care) DEVICE

Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.

Arm 2 - EH

Eligibility Criteria

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

You may qualify if:

• Tracheostomy patient outside critical care
• Self-ventilating via a tracheostomy tube, independent of cuff status
• years or older

You may not qualify if:

• Patients with tidal volume beyond recommended range (50-1000 ml)
• Dehydration
• Very heavy/excessive secretion from the lungs and airways (requiring more frequently tracheal suction, more than hourly suctioning)
• High oxygen need (FiO2 \> 0.4)
• Acutely deteriorating patient

Sponsors & Collaborators

• Atos Medical AB: lead
• Barts & The London NHS Trust: collaborator

Study Sites (1)

The Royal London Hospital, Barts Health NHS Trust

London, United Kingdom

Location

Study Officials

• Amanda Thomas, Dr

  The Royal London Hospital, Barts Health NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single-center, two-armed randomized controlled trial with a subsequent feasibility phase, transitioning control-group patients to investigational device arm

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: July 5, 2024
• Study Start: February 5, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)