Clinical trial NCT06487104: Use of TrachPhone in Tracheostomized Patients
Official title: Safety, Feasibility, and Impact on Pulmonary Secretion Management Comparing the Use of TrachPhone and External Humidifier After Tracheostomy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tracheostomy
Keywords: Heat and Moisture Exchangers
Secretion
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: Barts & The London NHS Trust
First posted: 2024-07-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, two-armed randomized controlled trial with a subsequent feasibility phase, transitioning control-group patients to investigational device arm
Primary purpose: OTHER

Brief 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 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

Primary outcomes:
measure: Number of suctioning per day
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Secondary outcomes:
measure: Time needed for suctioning
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
measure: Quality of secretion
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
measure: Quality of Life by EQ-5D-5L
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
measure: Use of TrachPhone
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
measure: Patient preference
timeFrame: Upon discharge from the hospital (on average after 3 weeks)
measure: Nurse and therapy team feedback
timeFrame: Upon discharge of the last participant, on average after 1 year
measure: Nursing time regarding device use
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
measure: Adherence to use of devices
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
measure: Patient communication
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
measure: Voice Quality
timeFrame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
measure: Patient mobility
timeFrame: Upon discharge of the last participant, on average after 1 year
measure: Oxygen needs
timeFrame: At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge
measure: Adverse Events
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal London Hospital, Barts Health NHS Trust
Study officials:
affiliation: The Royal London Hospital, Barts Health NHS Trust
name: Amanda Thomas, Dr
role: PRINCIPAL_INVESTIGATOR
References: