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

Conditions

• Patient Satisfaction
• Pulmonary Rehabilitation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TrachPhone Heat Moisture Exchange — DEVICE
  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 — DEVICE
  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

Study Details

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 Dates

First listed

Sep 1, 2026

Start date

Oct 1, 2026

Status verified

Aug 2026

Primary completion

Oct 1, 2027

Completion

Jan 30, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental- Participants who will receive the TrachPhone HME
  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.
• Active Comparator: Control group- Participants who will be provided standard of care for tracheostomy management
  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.

Primary Outcome Measure

The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients. [ Time Frame: From perioperative day 2 to day of hospital discharge day. ]

Central Contacts

• Jennifer T Larsson, MS, CCC-SLP
  9545522142
  [email protected]
• Melanie Shaha, MS, CCC-SLP
  720-232-4585
  [email protected]

Locations (2)

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