Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients
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.
Checked against the public recordLast updated Sep 1, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- University of South Florida
- Interventions being studied
- Device: TrachPhone Heat Moisture Exchange; Device: Trach Collar
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Tampa General HospitalTampa, Florida
- University of South FloridaTampa, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 1, 2026. Always confirm current availability with the study team.