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.
Patients over 18 years old with diagnosis of head and neck cancer who received a tracheostomy after their surgery in the acute care setting.
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.
Parallel
TrachPhone Heat Moisture Exchange
DeviceThe 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
DeviceA 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
The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.
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.
The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.
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.
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University of South Florida
Lead sponsor
Atos Medical AB
Collaborator
Tampa General Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
