Use of TrachPhone in Tracheostomized Patients

Enrolling by invitation · Not applicable

Conditions studied: Tracheostomy

In brief

The use of Heat and Moisture Exchangers (HMEs) and their positive impact on pulmonary health have been extensively studied in patients with head and neck cancer but have not been systematically explored in other patient populations breathing through a neck stoma. The objective of this clinical investigation is to compare the use of HMEs to the use of External Humidifiers (EHs) on pulmonary secretion management, their usability and safety, for humidifying inhaled air in patients that received a tracheostomy due to a neurological condition.

Key facts

Study ID

NCT06487104

Run by

Atos Medical AB

People needed

22

Starts

2025-02-05

Expected to finish

2026-12-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Tracheostomy patient outside critical care
• Self-ventilating via a tracheostomy tube, independent of cuff status
• 18 years or older

You may not qualify if…

• Patients with tidal volume beyond recommended range (50-1000 ml)
• Dehydration
• Very heavy/excessive secretion from the lungs and airways (requiring more frequently tracheal suction, more than hourly suctioning)
• High oxygen need (FiO2 > 0.4)
• Acutely deteriorating patient

Where it is running

• The Royal London Hospital, Barts Health NHS Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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