Clinical trial · Interventional
Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patient Satisfaction | — | UNRESOLVED | — |
| Pulmonary Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trach Collar | Device | — | UNRESOLVED |
| TrachPhone Heat Moisture Exchange | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental- Participants who will receive the TrachPhone HME
- description
- 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.
- interventionNames
- Device: TrachPhone Heat Moisture Exchange
- type
- ACTIVE_COMPARATOR
- label
- Control group- Participants who will be provided standard of care for tracheostomy management
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years old with diagnosis of head and neck cancer who received a tracheostomy after their surgery in the acute care setting. Exclusion Criteria: * 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.
References
Publications (1)
- BACKGROUNDKearney 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 37161949