Use of TrachPhone in Tracheostomized Patients

Launched by ATOS MEDICAL AB · Jul 2, 2024

Keywords

ClinConnect Summary

This study is testing whether using a heat-and-moisture exchanger (HME) device called TrachPhone to humidify air for people with a tracheostomy is more helpful than using an External Humidifier (EH). It’s a small, single-center, randomized trial in London that will enroll about 22 adults who have a tracheostomy due to neurological conditions. Participants are randomly assigned to start with the TrachPhone HME (Arm 1) or with the External Humidifier (Arm 2), and then Arm 2 switches to the TrachPhone after the first follow-up. The study started in February 2025 and is expected to finish around October 2025. No results are available yet.

To be eligible, adults 18 and older with a tracheostomy who can breathe on their own (not in critical care) can participate. Certain conditions exclude people, such as very large or very tiny breathing volumes, dehydration, heavy airway secretions needing frequent suctioning, high oxygen needs, or acute illness. If you participate, you’ll use the assigned humidification method around the clock and have follow-up checks at baseline, about day 10, and roughly every 10 days until discharge (about 3 weeks on average). Researchers will look at how often suctioning is needed, how long it takes, the quality of secretions, quality of life, device use and comfort, patient and staff feedback, nursing time, adherence, communication and voice, mobility, oxygen needs, and safety events. The study is led by The Royal London Hospital and sponsored by Atos Medical AB. No personal data will be shared outside the study, and results will be reported after completion.

Gender

ALL

Eligibility criteria

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