Use of TrachPhone in Tracheostomized Patients

Atos Medical

Status: Invitation-only

Conditions: Tracheostomy

Treatments: Device: TrachPhone HME; Device: External Humidifier (Usual Care)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06487104

TrachPhone

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Arm 1 - HME

Experimental group

Description:

24/7 use of TrachPhone HME for the entirety of study

Treatment:

Device: TrachPhone HME

Arm 2 - EH

Active Comparator group

Description:

24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation.

Treatment:

Device: External Humidifier (Usual Care)

Device: TrachPhone HME