Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTrachPhone Heat Moisture Exchange and Trach Collar

The study team can explain what participation involves.

Who it may be forPatient Satisfaction · Pulmonary Rehabilitation

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 1, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Not Yet Recruiting

The study is not accepting participants yet.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?University of South Florida

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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