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Use of TrachPhone in Tracheostomized Patients

NCT06487104 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Barts & The London NHS Trust

    collaborator OTHER

  • Atos Medical AB

    lead INDUSTRY

Principal Investigators

  • Amanda Thomas, Dr · The Royal London Hospital, Barts Health NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-05
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06487104 on ClinicalTrials.gov