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Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients
Sponsor: University of South Florida
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-10-01
Completion Date
2028-01-30
Last Updated
2026-09-01
Healthy Volunteers
No
Interventions
TrachPhone Heat Moisture Exchange
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 Collar
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
Locations (2)
Tampa General Hospital
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States