Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old with diagnosis of head and neck cancer who received a tracheostomy after their surgery in the acute care setting.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: TrachPhone Heat Moisture Exchange (Device)
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.
干预措施: Trach Collar (Device)
结局指标
主要结局
The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.
时间窗: 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.
次要结局
- The effectiveness of Trachphone HME on both patient satisfaction as well as improved pulmonary function with tracheostomized head and neck cancer patients.(From perioperative day 2 through day of hospital discharge day.)
研究者
Jennifer Larsson
Speech-Language Pathologist
University of South Florida