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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

NCT07798414 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-09-01

No results posted yet for this 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.

Conditions

  • Patient Satisfaction
  • Pulmonary Rehabilitation

Interventions

DEVICE

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.

DEVICE

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

Sponsors & Collaborators

  • Atos Medical AB

    collaborator INDUSTRY

  • Tampa General Hospital

    collaborator OTHER

  • University of South Florida

    lead OTHER

Principal Investigators

  • Jennifer Larsson, MS, CCC-SLP · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-10-01
Completion
2028-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07798414 on ClinicalTrials.gov