Patient SatisfactionPhase 1/2HMENCT07798414
Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients
A Phase 1/2 study testing TrachPhone Heat Moisture Exchange and Trach Collar in people with Patient Satisfaction and Pulmonary Rehabilitation, run by University of South Florida at 2 sites in United States.
Trial summary
This study is being conducted at Tampa General Hospital. This study aims to evaluate the effectiveness of TrachPhone Heat Moisture Exchange (HME) on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Pulmonary Rehabilitation
- What is being tested?
- TrachPhone Heat Moisture Exchange and Trach Collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2026to 30 Jan 2028
- Phase
- Phase 1/2
- 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
- Patients over 18 years old with diagnosis of head and neck cancer who received a tracheostomy after their surgery in the acute care setting.
Who cannot join
- Patients with head and neck cancer who did not receive a tracheostomy in the post-operative period.
- Patients with tracheostomy on mechanical ventilation in the post-operative period.
- Patients who are unable to don on/off the TrachPhone HME.
- Patients who has a cuffed tracheostomy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Tampa General Hospital
Tampa, Florida, 33626
University of South Florida
Tampa, Florida, 33626
Jennifer T Larsson, MS, CCC-SLP, 9545522142, Jlarsson@usf.edu
Melanie Shaha, MS, CCC-SLP, 720-232-4585, melanieshaha@usf.edu
About this study
This study is being conducted at Tampa General Hospital. This study aims to evaluate the effectiveness of TrachPhone Heat Moisture Exchange (HME) on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients. Enrolled participants will be randomly assigned to either the experimental or control group using a computer-generated randomization list. Participants will be assigned to groups sequentially in the order they are enrolled. As a participant in the experimental group, we will consult you during your stay in the hospital at most 2 times for monitoring per standard of care and collection of data. As a participant in the control group, we will consult with you during your stay 2 times for monitoring as part of standard of care.
Read the detailed description
The research on the TrachPhone HME for tracheostomized patients are limited (Kearney, et al, 2023). Furthermore, this research study is highly warranted to demonstrate that the use of an HME filter for tracheostomized patients improves pulmonary function and can even allow patients to voice, improving their quality of life.
The purpose of the use of Trachphone for tracheostomized head and neck cancer patients in the post-operative acute care setting to improve pulmonary rehabilitation, pulmonary function and improve patient satisfaction. The TrachPhone is a multifunctional HME providing heat and moisture, it has a speaking valve function, integrated oxygen supply port, integrated tracheal suctioning port allowing for tracheal suctioning without having to remove the HME, and foam filter.
Following surgery, eligible patients will be identified and approached by a Speech-Language Pathologist (SLP) during the post-operative period (days 1-3). Patients who express interest will be provided with a full explanation of the study, after which written informed consent will be obtained prior to enrollment. Enrolled participants will be randomly assigned to either the experimental or control group using a computer-generated randomization list. Participants will be assigned to groups sequentially in the order they are enrolled.
Randomized controlled clinical trial for 80 tracheostomized head and neck cancer patient within post operative day 1-3 (40 participants in the control group not using Trachphone and 40 participants in the experimental group with TrachPhone HME application).
Experimental Group (TrachPhone HME) Within post-operative days 1-3, participants assigned to the experimental group will be fitted with the TrachPhone Heat and Moisture Exchanger (HME), placed directly on the open tracheostomy. At enrollment, baseline data will be collected, including vital signs, completion of the Tracheostomy Wellbeing Score (TWS), and suctioning frequency as documented in the electronic health record (Epic). Participants will wear the TrachPhone continuously as tolerated, per nursing communication order. The SLP will conduct a follow-up assessment 1-2 days prior to or on the day of decannulation or discharge, at which time vital signs, TWS, and suctioning frequency will be reassessed.
Control Group (Standard Trach Collar).
Participants assigned to the control group will receive standard tracheostomy care with a trach collar in place. At enrollment, identical baseline measures will be collected, including vital signs, TWS completion, and suctioning frequency via Epic nursing documentation. Participants will wear the trach collar continuously as tolerated, per nursing communication order. The SLP will conduct a follow-up assessment 1-2 days prior to or on the day of decannulation or discharge, collecting the same outcome measures as baseline.
Procedures conducted is per standard of care assessing vitals of a tracheostomized patient. The procedures that will be conducted solely for the purpose of the study will be use of TrachPhone HME, monitoring frequency of required suctioning and vitals, and providing patient with a Tracheostomy Wellbeing Score.
- Conditions
- Patient Satisfaction, Pulmonary Rehabilitation
- Being tested
- TrachPhone Heat Moisture Exchange, Trach Collar
- Keywords
- Tracheostomy, HME, head and neck cancer
- Medical subject headings
- Patient Satisfaction, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrachPhone Heat Moisture ExchangeDevice
The purpose of the use of Trachphone for tracheostomized head and neck cancer patients in the post-operative acute care setting to improve pulmonary rehabilitation, pulmonary function and improve patient satisfaction. The TrachPhone is a multifunctional HME providing heat and moisture, it has a speaking valve function, integrated oxygen supply port, integrated tracheal suctioning port allowing for tracheal suctioning without having to remove the HME, and foam filter.
Trach CollarDevice
A tracheostomy collar (or trach collar) is a flexible plastic mask that fits over a tracheostomy tube in the neck to deliver humidified oxygen or room air to a patient who is breathing on their own
| Study group | Role | What they receive |
|---|---|---|
| Experimental- Participants who will receive the TrachPhone HME | Experimental | Within post-operative days 1-3, participants assigned to the experimental group will be fitted with the TrachPhone Heat and Moisture Exchanger (HME), placed directly on the open tracheostomy. At enrollment, baseline data will be collected, including vital signs, completion of the Tracheostomy Wellbeing Score (TWS), and suctioning frequency as documented in the electronic health record (Epic). Participants will wear the TrachPhone continuously as tolerated, per nursing communication order. The SLP will conduct a follow-up assessment 1-2 days prior to or on the day of decannulation or discharge, at which time vital signs, TWS, and suctioning frequency will be reassessed. Receives: Device: TrachPhone Heat Moisture Exchange |
| Control group- Participants who will be provided standard of care for tracheostomy management | Active comparator | Participants assigned to the control group will receive standard tracheostomy care with a trach collar in place. At enrollment, identical baseline measures will be collected, including vital signs, TWS completion, and suctioning frequency via Epic nursing documentation. Participants will wear the trach collar continuously as tolerated, per nursing communication order. The SLP will conduct a follow-up assessment 1-2 days prior to or on the day of decannulation or discharge, collecting the same outcome measures as baseline. Receives: Device: Trach Collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.
To describe the effectiveness of TrachPhone Heat Moisture Exchanger (HME) on patient satisfaction via completion of the completion of the Tracheostomy Wellbeing Score (TWS). The Tracheostomy Well-Being Score (TWBS) is a 12-item patient-reported questionnaire designed to measure the impact of a tracheostomy on a patient's well-being across six key domains. It is intended for use in critically ill patients and other tracheostomized individuals to assess subjective comfort and quality of life. Each item is scored on a 4-point scale (0-3) based on frequency of occurrence (Never = 0, Sometimes = 1, Often = 2, Always = 3). Higher total scores indicate greater perceived burden or discomfort.
Measured: From perioperative day 2 to day of hospital discharge day.
Secondary outcomes (1)
The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.
To describe the effectiveness of TrachPhone Heat Mositure Exchanger (HME) on pulmonary rehabilitation post-op for head and neck cancer patients by collecting data on vital signs (respiratory rate (RR) , heart rate (BPM) and oxygen saturation (SpO2) as well as suction frequency.
Measured: From perioperative day 2 through day of hospital discharge day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial- will have a control and experimental group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Atos Medical AB, Tampa General Hospital
- Responsible party
- Principal investigator, Jennifer Larsson, University of South Florida
- Investigators
- Jennifer Larsson, MS, CCC-SLP, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798414
- Sponsor's protocol ID
- Study007731
- Acronym
- HME
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Kearney A, Norris K, Bertelsen C, Samad I, Cambridge M, Croft G, Peavler S, Groen C, Doyle PC, Damrose EJ. Adoption and Utilization of Heat and Moisture Exchangers (HMEs) in the Tracheostomy Patient. Otolaryngol Head Neck Surg. 2023 Nov;169(5):1374-1381. doi: 10.1002/ohn.368. Epub 2023 May 10.
PubMed 37161949
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT07798414
- Acronym / sponsor ID
- HME / Study007731
- Conditions
- Patient Satisfaction, Pulmonary Rehabilitation
- Keywords
- Tracheostomy, HME, head and neck cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Atos Medical AB, Tampa General Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 1 Sep 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.
This study is being conducted at Tampa General Hospital. This study aims to evaluate the effectiveness of TrachPhone Heat Moisture Exchange (HME) on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients. Enrolled participants will be randomly assigned to either the experimental or control group using a computer-generated randomization list. Participants will be assigned to groups sequentially in the order they are enrolled. As a participant in the experimental group, we will consult you during your stay in the hospital at most 2 times for monitoring per standard of care and collection of data. As a participant in the control group, we will consult with you during your stay 2 times for monitoring as part of standard of care.
Detailed description
The research on the TrachPhone HME for tracheostomized patients are limited (Kearney, et al, 2023). Furthermore, this research study is highly warranted to demonstrate that the use of an HME filter for tracheostomized patients improves pulmonary function and can even allow patients to voice, improving their quality of life.
The purpose of the use of Trachphone for tracheostomized head and neck cancer patients in the post-operative acute care setting to improve pulmonary rehabilitation, pulmonary function and improve patient satisfaction. The TrachPhone is a multifunctional HME providing heat and moisture, it has a speaking valve function, integrated oxygen supply port, integrated tracheal suctioning port allowing for tracheal suctioning without having to remove the HME, and foam filter.
Following surgery, eligible patients will be identified and approached by a Speech-Language Pathologist (SLP) during the post-operative period (days 1-3). Patients who express interest will be provided with a full explanation of the study, after which written informed consent will be obtained prior to enrollment. Enrolled participants will be randomly assigned to either the experimental or control group using a computer-generated randomization list. Participants will be assigned to groups sequentially in the order they are enrolled.
Randomized controlled clinical trial for 80 tracheostomized head and neck cancer patient within post operative day 1-3 (40 participants in the control group not using Trachphone and 40 participants in the experimental group with TrachPhone HME application).
Experimental Group (TrachPhone HME) Within post-operative days 1-3, participants assigned to the experimental group will be fitted with the TrachPhone Heat and Moisture Exchanger (HME), placed directly on the open tracheostomy. At enrollment, baseline data will be collected, including vital signs, completion of the Tracheostomy Wellbeing Score (TWS), and suctioning frequency as documented in the electronic health record (Epic). Participants will wear the TrachPhone continuously as tolerated, per nursing communication order. The SLP will conduct a follow-up assessment 1-2 days prior to or on the day of decannulation or discharge, at which time vital signs, TWS, and suctioning frequency will be reassessed.
Control Group (Standard Trach Collar).
Participants assigned to the control group will receive standard tracheostomy care with a trach collar in place. At enrollment, identical baseline measures will be collected, including vital signs, TWS completion, and suctioning frequency via Epic nursing documentation. Participants will wear the trach collar continuously as tolerated, per nursing communication order. The SLP will conduct a follow-up assessment 1-2 days prior to or on the day of decannulation or discharge, collecting the same outcome measures as baseline.
Procedures conducted is per standard of care assessing vitals of a tracheostomized patient. The procedures that will be conducted solely for the purpose of the study will be use of TrachPhone HME, monitoring frequency of required suctioning and vitals, and providing patient with a Tracheostomy Wellbeing Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial- will have a control and experimental group
| Arm | Type | Receives |
|---|---|---|
| Experimental- Participants who will receive the TrachPhone HME | Experimental | Device: TrachPhone Heat Moisture ExchangeWithin post-operative days 1-3, participants assigned to the experimental group will be fitted with the TrachPhone Heat and Moisture Exchanger (HME), placed directly on the open tracheostomy. At enrollment, baseline data will be collected, including vital signs, completion of the Tracheostomy Wellbeing Score (TWS), and suctioning frequency as documented in the electronic health record (Epic). Participants will wear the TrachPhone continuously as tolerated, per nursing communication order. The SLP will conduct a follow-up assessment 1-2 days prior to or on the day of decannulation or discharge, at which time vital signs, TWS, and suctioning frequency will be reassessed. |
| Control group- Participants who will be provided standard of care for tracheostomy management | Active comparator | Device: Trach CollarParticipants assigned to the control group will receive standard tracheostomy care with a trach collar in place. At enrollment, identical baseline measures will be collected, including vital signs, TWS completion, and suctioning frequency via Epic nursing documentation. Participants will wear the trach collar continuously as tolerated, per nursing communication order. The SLP will conduct a follow-up assessment 1-2 days prior to or on the day of decannulation or discharge, collecting the same outcome measures as baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old with diagnosis of head and neck cancer who received a tracheostomy after their surgery in the acute care setting.
Key exclusion criteria (4 listed)
- Patients with head and neck cancer who did not receive a tracheostomy in the post-operative period.
- Patients with tracheostomy on mechanical ventilation in the post-operative period.
- Patients who are unable to don on/off the TrachPhone HME.
- Patients who has a cuffed tracheostomy.
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 Heat Moisture ExchangeThe purpose of the use of Trachphone for tracheostomized head and neck cancer patients in the post-operative acute care setting to improve pulmonary rehabilitation, pulmonary function and improve patient satisfaction. The TrachPhone is a multifunctional HME providing heat and moisture, it has a speaking valve function, integrated oxygen supply port, integrated tracheal suctioning port allowing for tracheal suctioning without having to remove the HME, and foam filter. | Device | Experimental- Participants who will receive the TrachPhone HME |
| Trach CollarA tracheostomy collar (or trach collar) is a flexible plastic mask that fits over a tracheostomy tube in the neck to deliver humidified oxygen or room air to a patient who is breathing on their own | Device | Control group- Participants who will be provided standard of care for tracheostomy management |
Primary outcome
The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.
Time frame: From perioperative day 2 to day of hospital discharge day.
To describe the effectiveness of TrachPhone Heat Moisture Exchanger (HME) on patient satisfaction via completion of the completion of the Tracheostomy Wellbeing Score (TWS). The Tracheostomy Well-Being Score (TWBS) is a 12-item patient-reported questionnaire designed to measure the impact of a tracheostomy on a patient's well-being across six key domains. It is intended for use in critically ill patients and other tracheostomized individuals to assess subjective comfort and quality of life. Each item is scored on a 4-point scale (0-3) based on frequency of occurrence (Never = 0, Sometimes = 1, Often = 2, Always = 3). Higher total scores indicate greater perceived burden or discomfort.
1 secondary outcome
The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.
Time frame: From perioperative day 2 through day of hospital discharge day.
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 1 Sep 2026.
- Background: PubMed 37161949Kearney A, Norris K, Bertelsen C, Samad I, Cambridge M, Croft G, Peavler S, Groen C, Doyle PC, Damrose EJ. Adoption and Utilization of Heat and Moisture Exchangers (HMEs) in the Tracheostomy Patient. Otolaryngol Head Neck Surg. 2023 Nov;169(5):1374-1381. doi: 10.1002/ohn.368. Epub 2023 May 10.
- TrachPhone HMELink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Jennifer Larsson, MS, CCC-SLP principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TrachPhone Heat Moisture Exchange and Trach Collar in people with Patient Satisfaction and Pulmonary Rehabilitation, run by University of South Florida at 2 sites in United States.
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 1 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jennifer T Larsson, MS, CCC-SLP (9545522142, Jlarsson@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients. (time frame: From perioperative day 2 to day of hospital discharge day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07798414, which also lists 1 linked publication.
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 1 Sep 2026.