TracheostomyNCT06487104
Use of TrachPhone in Tracheostomized Patients
A study testing TrachPhone HME in people with Tracheostomy, run by Atos Medical AB at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy
- What is being tested?
- TrachPhone HME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tracheostomy patient outside critical care
- Self-ventilating via a tracheostomy tube, independent of cuff status
- 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Royal London Hospital, Barts Health NHS Trust
London
About this study
Official title: 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.
- Conditions
- Tracheostomy
- Being tested
- TrachPhone HME, External Humidifier (Usual Care)
- Keywords
- Heat and Moisture Exchangers, Secretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrachPhone HMEDevice
Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients.
The TrachPhone HME is an HME specifically designed for tracheostomy patients.
External Humidifier (Usual Care)Device
Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - HME | Experimental | 24/7 use of TrachPhone HME for the entirety of study Receives: 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. Receives: Device: TrachPhone HME; Device: External Humidifier (Usual Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of suctioning per day
Times per day suctioning is required
Measured: 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
Minutes per day of suctioning
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Upon discharge from the hospital (on average after 3 weeks)
Nurse and therapy team feedback
Staff impression and preference measured by nurse survey
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge
Adverse Events
Any incidents reported throughout study duration
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start5 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, two-armed randomized controlled trial with a subsequent feasibility phase, transitioning control-group patients to investigational device arm
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- Amanda Thomas, Dr, Principal investigator, The Royal London Hospital, Barts Health NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487104
- Sponsor's protocol ID
- TrachPhone
- Status last verified
- Jul 2026
- First submitted
- 5 Apr 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility, and Impact on Pulmonary Secretion Management Comparing the Use of TrachPhone and External Humidifier After Tracheostomy
- ClinicalTrials.gov ID
- NCT06487104
- Acronym / sponsor ID
- TrachPhone
- Conditions
- Tracheostomy
- Keywords
- Heat and Moisture Exchangers, Secretion
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Barts & The London NHS Trust
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, two-armed randomized controlled trial with a subsequent feasibility phase, transitioning control-group patients to investigational device arm
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - HME | Experimental | Device: TrachPhone HME24/7 use of TrachPhone HME for the entirety of study |
| Arm 2 - EH | Active comparator | Device: TrachPhone HME, Device: External Humidifier (Usual Care)24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tracheostomy patient outside critical care
- Self-ventilating via a tracheostomy tube, independent of cuff status
- 18 years or older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrachPhone HMEUse of TrachPhone HME for humidification of inhaled air in tracheostomized patients. The TrachPhone HME is an HME specifically designed for tracheostomy patients. | Device | Arm 1 - HME, Arm 2 - EH |
| External Humidifier (Usual Care)Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients. | Device | Arm 2 - EH |
Primary outcome
Number of suctioning per day
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Times per day suctioning is required
13 secondary outcomes
Time needed for suctioning
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Quality of secretion
Time frame: 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
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Use of TrachPhone
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Patient preference
Time frame: Upon discharge from the hospital (on average after 3 weeks)
Nurse and therapy team feedback
Time frame: Upon discharge of the last participant, on average after 1 year
Nursing time regarding device use
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Adherence to use of devices
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Patient communication
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Voice Quality
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Patient mobility
Time frame: Upon discharge of the last participant, on average after 1 year
Oxygen needs
Time frame: At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge
Adverse Events
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Thomas, Dr principal investigator
The Royal London Hospital, Barts Health NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrachPhone HME in people with Tracheostomy, run by Atos Medical AB at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of suctioning per day (time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.