Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients (HME)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research on the TrachPhone HME for tracheostomized patients are limited (Kearney, et al, 2023). Furthermore, this research study is highly warranted to demonstrate that the use of an HME filter for tracheostomized patients improves pulmonary function and can even allow patients to voice, improving their quality of life.
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.
Following surgery, eligible patients will be identified and approached by a Speech-Language Pathologist (SLP) during the post-operative period (days 1-3). Patients who express interest will be provided with a full explanation of the study, after which written informed consent will be obtained prior to enrollment. 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.
Randomized controlled clinical trial for 80 tracheostomized head and neck cancer patient within post operative day 1-3 (40 participants in the control group not using Trachphone and 40 participants in the experimental group with TrachPhone HME application).
Experimental Group (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.
Control Group (Standard Trach Collar).
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.
Procedures conducted is per standard of care assessing vitals of a tracheostomized patient. The procedures that will be conducted solely for the purpose of the study will be use of TrachPhone HME, monitoring frequency of required suctioning and vitals, and providing patient with a Tracheostomy Wellbeing Score.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Jennifer T Larsson, MS, CCC-SLP
- Phone Number: 9545522142
- Email: Jlarsson@usf.edu
Study Contact Backup
- Name: Melanie Shaha, MS, CCC-SLP
- Phone Number: 720-232-4585
- Email: melanieshaha@usf.edu
Study Locations
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Florida
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Tampa, Florida, United States, 33626
- Tampa General Hospital
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Tampa, Florida, United States, 33626
- University of South Florida
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Contact:
- Jennifer T Larsson, MS, CCC-SLP
- Phone Number: 9545522142
- Email: Jlarsson@usf.edu
-
Contact:
- Melanie Shaha, MS, CCC-SLP
- Phone Number: 720-232-4585
- Email: melanieshaha@usf.edu
-
Sub-Investigator:
- Morgan Trubilla, MS, CCC-SLP
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Sub-Investigator:
- Tara Segalewitz, MS CCC-SLP
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Sub-Investigator:
- Ashley Thomas, MS, CCC-SLP
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion 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.
Exclusion 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
To describe the effectiveness of TrachPhone Heat Moisture Exchanger (HME) on patient satisfaction via completion of the completion of the Tracheostomy Wellbeing Score (TWS).
The Tracheostomy Well-Being Score (TWBS) is a 12-item patient-reported questionnaire designed to measure the impact of a tracheostomy on a patient's well-being across six key domains.
It is intended for use in critically ill patients and other tracheostomized individuals to assess subjective comfort and quality of life.
Each item is scored on a 4-point scale (0-3) based on frequency of occurrence (Never = 0, Sometimes = 1, Often = 2, Always = 3).
Higher total scores indicate greater perceived burden or discomfort.
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From perioperative day 2 to day of hospital discharge day.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 through day of hospital discharge day.
|
To describe the effectiveness of TrachPhone Heat Mositure Exchanger (HME) on pulmonary rehabilitation post-op for head and neck cancer patients by collecting data on vital signs (respiratory rate (RR) , heart rate (BPM) and oxygen saturation (SpO2) as well as suction frequency.
|
From perioperative day 2 through day of hospital discharge day.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Larsson, MS, CCC-SLP, University of South Florida
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study007731
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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