NCT06487104

Use of TrachPhone in Tracheostomized Patients

Safety, Feasibility, and Impact on Pulmonary Secretion Management Comparing the Use of TrachPhone and External Humidifier After Tracheostomy

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Atos Medical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tracheostomy

Interventions

Type	Name	Description
DEVICE	TrachPhone HME	Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients. The TrachPhone HME is an HME specifically designed for tracheostomy patients.
DEVICE	External Humidifier (Usual Care)	Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.

Timeline

• Start date: 2025-02-05
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-07-05
• Last updated: 2025-12-01

Locations

1 site across 1 country: United Kingdom