Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients
HME
1 other identifier
interventional
80
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2026
CompletedFirst Posted
Study publicly available on registry
September 1, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2028
September 1, 2026
August 1, 2026
1 year
August 19, 2026
August 27, 2026
Conditions
Keywords
Outcome Measures
Primary 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 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.
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.
From perioperative day 2 through day of hospital discharge day.
Study Arms (2)
Experimental- Participants who will receive the TrachPhone HME
EXPERIMENTALWithin 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 COMPARATORParticipants 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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Patients over 18 years old with diagnosis of head and neck cancer who received a tracheostomy after their surgery in the acute care setting.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atos Medical ABcollaborator
- Tampa General Hospitalcollaborator
- University of South Floridalead
Study Sites (2)
Tampa General Hospital
Tampa, Florida, 33626, United States
University of South Florida
Tampa, Florida, 33626, United States
Related Publications (1)
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.
PMID: 37161949BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Larsson, MS, CCC-SLP
University of South Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Speech-Language Pathologist
Study Record Dates
First Submitted
August 19, 2026
First Posted
September 1, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
January 30, 2028
Last Updated
September 1, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR