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

The research on the TrachPhone HME for tracheostomized patients are limited (Kearney, etal, 2023). Furthermore, this research study is highly warranted to demonstrate that theuse of an HME filter for tracheostomized patients improves pulmonary function and caneven allow patients to voice, improving their quality of life.The purpose of the use of Trachphone for tracheostomized head and neck cancer patients inthe post‐operative acute care setting to improve pulmonary rehabilitation, pulmonaryfunction and improve patient satisfaction. The TrachPhone is a multifunctional HMEproviding heat and moisture, it has a speaking valve function, integrated oxygen supplyport, integrated tracheal suctioning port allowing for tracheal suctioning without havingto remove the HME, and foam filter.Following surgery, eligible patients will be identified and approached by aSpeech‐Language Pathologist (SLP) during the post‐operative period (days 1‐3). Patientswho express interest will be provided with a full explanation of the study, after whichwritten informed consent will be obtained prior to enrollment. Enrolled participants willbe randomly assigned to either the experimental or control group using acomputer‐generated randomization list. Participants will be assigned to groupssequentially in the order they are enrolled.Randomized controlled clinical trial for 80 tracheostomized head and neck cancer patientwithin post operative day 1‐3 (40 participants in the control group not using Trachphoneand 40 participants in the experimental group with TrachPhone HME application).Experimental Group (TrachPhone HME) Within post‐operative days 1‐3, participants assignedto 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 becollected, 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 nursingcommunication order. The SLP will conduct a follow‐up assessment 1‐2 days prior to or onthe day of decannulation or discharge, at which time vital signs, TWS, and suctioningfrequency will be reassessed.Control Group (Standard Trach Collar).Participants assigned to the control group will receive standard tracheostomy care with atrach collar in place. At enrollment, identical baseline measures will be collected,including vital signs, TWS completion, and suctioning frequency via Epic nursingdocumentation. Participants will wear the trach collar continuously as tolerated, pernursing communication order. The SLP will conduct a follow‐up assessment 1‐2 days priorto or on the day of decannulation or discharge, collecting the same outcome measures asbaseline.Procedures conducted is per standard of care assessing vitals of a tracheostomizedpatient. The procedures that will be conducted solely for the purpose of the study willbe use of TrachPhone HME, monitoring frequency of required suctioning and vitals, andproviding patient with a Tracheostomy Wellbeing Score.