TracheostomyNCT07862023
Trachphone vs Warm Air Humidification for Acute Trache Patients on ICU
An observational study of Tracheostomy and Ventilated Patients, run by Tameside General Hospital at 1 site in United Kingdom.
Trial summary
A tracheostomy is a surgical opening made in the windpipe (trachea) through the neck to help a person breathe. A tube is placed in the opening to keep it open. As a result, the air reaching the lungs can be cooler, drier and less well filtered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Ventilated Patients, Critical Care
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2026to 31 Aug 2027
- Phase
- Observational
- 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
Study population: The investigators are inviting patients aged 18 years or older, who have been admitted to the critical care unit at Tameside Hospital and have undergone a tracheostomy, to participate in this study.
Who may be able to join
- Be aged 18 years or older
- Have undergone acute tracheostomy
- Be admitted to Critical Care
- Be mechanically ventilated
- Be clinically suitable for TrachPhone™
- Provide informed consent or have consultee agreement obtained
- Staff that have cared for an eligible participant will be invited to participate
Who cannot join
- Are under 18 years of age
- Have a clinical contraindication to TrachPhone™
- Are receiving end-of-life care
- Are considered unsuitable by the treating consultant
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
Tameside and Glossop Integrated Care NHS Foundation Trust
Ashton-under-Lyne, OL6 9RW
Rebecca Roberts, 01619224451, rd@tgh.nhs.uk
Helen Evans
About this study
Official title: An Observational Study to Understand the Impact of Trachphone for Patients With a Tracheostomy Verses Humidification Via Warm Air Circuit Ventilation
A tracheostomy is a surgical opening made in the windpipe (trachea) through the neck to help a person breathe. A tube is placed in the opening to keep it open. As a result, the air reaching the lungs can be cooler, drier and less well filtered. This can lead to thicker mucus, coughing, difficulty clearing secretions, and an increased risk of chest infections or breathing problems caused by mucus blockages. To help replace some of the moisture normally provided by the nose and throat, humidification is often used. Different methods of humidification are used in clinical practice, although approaches may vary between healthcare centres.
Although Heat and Moisture Exchangers (HMEs) have been available for many years for people with a tracheostomy who breathe independently, their use remains limited and varies across healthcare settings. Existing research suggests that HMEs are generally well tolerated and may help keep airway secretions thinner and easier to clear, however the evidence available is limited and further research is needed for a better understanding of the clinical benefits and limitations.
The purpose of this study is to compare two humidification methods used for tracheostomy patients receiving ventilator support in critical care: the TrachPhone, a single use Heat and Moisture Exchanger (HME) device and warm air ventilation humidification. The investigators want to understand whether either method offers advantages in secretion management, patient safety, comfort, and clinical outcomes.
- Conditions
- Tracheostomy, Ventilated Patients, Critical Care
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility and tolerability of TrachPhone
The primary outcome measure will be the feasibility and tolerability of TrachPhone™ when used as intended by both patients and staff. This will be a non-validated questionnaire using a satisfaction scale, ranging from very easy to very difficult, strongly agree to strongly disagree etc.
Measured: from enrollment to discharge or up to 30 days
Secondary outcomes (4)
Critical care length of stay
Number of days occupying a critical care bed
Measured: from enrollment to discharge, or up to 30 days
Patient mobility
Time from tracheostomy insertion to first mobilisation out of bed, Mobilisation milestones
Measured: Time from tracheostomy insertion to first mobilisation out of bed, assessed up to 30 days
Reported quality of life
Staff and Patient Questionnaires completed on discharge from critical care
Measured: on discharge, or up to 30 days
Patient communication ability
Ability to communicate wants and needs, Clinical observations, Patient questionnaire response, Staff questionnaire response
Measured: from enrollment to discharge, or up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tameside General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862023
- Sponsor's protocol ID
- 373876
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared outside the Trust
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Understand the Impact of Trachphone for Patients With a Tracheostomy Verses Humidification Via Warm Air Circuit Ventilation
- ClinicalTrials.gov ID
- NCT07862023
- Acronym / sponsor ID
- 373876
- Conditions
- Tracheostomy, Ventilated Patients, Critical Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tameside General HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
A tracheostomy is a surgical opening made in the windpipe (trachea) through the neck to help a person breathe. A tube is placed in the opening to keep it open. As a result, the air reaching the lungs can be cooler, drier and less well filtered. This can lead to thicker mucus, coughing, difficulty clearing secretions, and an increased risk of chest infections or breathing problems caused by mucus blockages. To help replace some of the moisture normally provided by the nose and throat, humidification is often used. Different methods of humidification are used in clinical practice, although approaches may vary between healthcare centres.
Although Heat and Moisture Exchangers (HMEs) have been available for many years for people with a tracheostomy who breathe independently, their use remains limited and varies across healthcare settings. Existing research suggests that HMEs are generally well tolerated and may help keep airway secretions thinner and easier to clear, however the evidence available is limited and further research is needed for a better understanding of the clinical benefits and limitations.
The purpose of this study is to compare two humidification methods used for tracheostomy patients receiving ventilator support in critical care: the TrachPhone, a single use Heat and Moisture Exchanger (HME) device and warm air ventilation humidification. The investigators want to understand whether either method offers advantages in secretion management, patient safety, comfort, and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators are inviting patients aged 18 years or older, who have been admitted to the critical care unit at Tameside Hospital and have undergone a tracheostomy, to participate in this study.
Key inclusion criteria (7 listed)
- Be aged 18 years or older
- Have undergone acute tracheostomy
- Be admitted to Critical Care
- Be mechanically ventilated
- Be clinically suitable for TrachPhone™
Key exclusion criteria (4 listed)
- Are under 18 years of age
- Have a clinical contraindication to TrachPhone™
- Are receiving end-of-life care
- Are considered unsuitable by the treating consultant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
feasibility and tolerability of TrachPhone
Time frame: from enrollment to discharge or up to 30 days
The primary outcome measure will be the feasibility and tolerability of TrachPhone™ when used as intended by both patients and staff. This will be a non-validated questionnaire using a satisfaction scale, ranging from very easy to very difficult, strongly agree to strongly disagree etc.
4 secondary outcomes
Critical care length of stay
Time frame: from enrollment to discharge, or up to 30 days
Patient mobility
Time frame: Time from tracheostomy insertion to first mobilisation out of bed, assessed up to 30 days
Reported quality of life
Time frame: on discharge, or up to 30 days
Patient communication ability
Time frame: from enrollment to discharge, or up to 30 days
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 7 Oct 2026.
- Individual participant dataSharing planned: No. individual participant data will not be shared outside the Trust
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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.
Tameside and Glossop Integrated Care NHS Foundation Trust
Ashton-under-Lyne, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy and Ventilated Patients, run by Tameside General Hospital 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility and tolerability of TrachPhone (time frame: from enrollment to discharge or up to 30 days). 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 7 Oct 2026.