Use of TrachPhone in Tracheostomized Patients

Safety, Feasibility, and Impact on Pulmonary Secretion Management Comparing the Use of TrachPhone and External Humidifier After Tracheostomy

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tracheostomy
• Intervention / Treatment: Device: TrachPhone HME; Device: External Humidifier (Usual Care)

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • The Royal London Hospital, Barts Health NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - HME; 24/7 use of TrachPhone HME for the entirety of study	Device: TrachPhone HME; Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients. The TrachPhone HME is an HME specifically designed for tracheostomy patients.
Active Comparator: Arm 2 - EH; 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; Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients. The TrachPhone HME is an HME specifically designed for tracheostomy patients.; Device: External Humidifier (Usual Care); Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed for suctioning	Minutes per day of suctioning	At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Quality of secretion	Amount and color 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	Patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility	At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Use of TrachPhone	% of patients using TrachPhone/tolerating TrachPhone recorded by study specific questionnaire	At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Patient preference	% of patients (participants that were assigned to Arm 2) recorded by study specific questionnaire	Upon discharge from the hospital (on average after 3 weeks)
Nurse and therapy team feedback	Staff impression and preference measured by nurse survey	Upon discharge of the last participant, on average after 1 year
Nursing time regarding device use	Minutes per day spent on device handling, recorded by nurse diary keeping, 3-day collection	At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Adherence to use of devices	Hours of use of each humidification method, recorded by study specific questionnaire	At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Patient communication	Communication by Therapy Outcome Measure for Voice Impairment (TOMS, score 0-5, higher score meaning no impairment)	At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Voice Quality	Patient reported, for participants speaking, through study specific questionnaire	At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Patient mobility	Staff perception of patient mobility and ease of transportation, measured though study specific questionnaires and nurse survey	Upon discharge of the last participant, on average after 1 year
Oxygen needs	Weaning of oxygen time needed measured by peripheral oxygen saturation (%) recorded in patient charts. Only for monitoring reasons.	At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge
Adverse Events	Any incidents reported throughout study duration	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Atos Medical AB
• Collaborators: Barts & The London NHS Trust
• Investigators: Principal Investigator: Amanda Thomas, Dr, The Royal London Hospital, Barts Health NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Secretion; Heat and Moisture Exchangers
• Other Study ID Numbers: TrachPhone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No