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NCT07798414Not yet recruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
80 (estimated)
First submitted
19 Aug 2026
Start date
1 Oct 2026
Primary completion date
1 Oct 2027
Lead sponsor
University of South Florida
NCT number
NCT07798414

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 80
  • From 1 Oct 2026 to the primary completion date, 1 Oct 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with head and neck cancer who did not receive a tracheostomy in the post-operative period.

Other

  • 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.

Who the study is looking for

  • Patients over 18 years old with diagnosis of head and neck cancer who received a tracheostomy after their surgery in the acute care setting.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of South Florida
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Tampa General Hospital
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.