TrachPhone HME for Head and Neck Cancer
(HME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jennifer Larsson, MS, CCC-SLP
Principal Investigator
University of South Florida
Are You a Good Fit for This Trial?
This trial is for people with head and neck cancer who have a tracheostomy (a breathing tube in their neck). Participants must be staying at Tampa General Hospital. Specific inclusion or exclusion criteria are not listed.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- TrachPhone Heat Moisture Exchange
Trial Overview
The study compares two devices used to help breathing after a tracheostomy: the TrachPhone Heat Moisture Exchange (HME) device versus the standard Trach Collar. Patients are randomly assigned to one of these groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Florida
Lead Sponsor
Atos Medical AB
Industry Sponsor
Tampa General Hospital
Collaborator
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