Use of TrachPhone in Tracheostomized Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

External Humidifier (Usual Care): Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.

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.

Eligibility

Primary outcome measure(s)

• Number of suctioning per day — At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
  Times per day suctioning is required

Trial sites (1)