RightFit
Not yet recruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study at Tampa General Hospital tests whether the TrachPhone HME, a device that exchanges heat and moisture, improves patient satisfaction and lung function. It is for adults with head and neck cancer who had a tracheostomy, an opening in the neck to help them breathe, after surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • You have head and neck cancer.
  • You had a tracheostomy after surgery while in the hospital for short-term care.

Who can't join

  • You did not have a tracheostomy after surgery.
  • You have a tracheostomy and need a breathing machine after surgery.
  • You cannot put on or take off the TrachPhone HME.
  • You have a cuffed tracheostomy tube, which has an inflatable seal around it.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

FL