Use of TrachPhone in Tracheostomized Patients
NCT Number: NCT06487104
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tracheostomy
Interventions: DEVICE: TrachPhone HME|DEVICE: External Humidifier (Usual Care)
Sponsor: Atos Medical AB
Collaborators: Barts & The London NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-10
Locations: The Royal London Hospital, Barts Health NHS Trust, London, United Kingdom

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.

Primary Outcome Measures: Number of suctioning per day, Times per day suctioning is required, At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Secondary Outcome Measures: Time needed for suctioning, Minutes per day of suctioning, At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)|Quality of secretion, Amount and color of secretion, At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)|Quality of Life by EQ-5D-5L, Patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility, At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)|Use of TrachPhone, % of patients using TrachPhone/tolerating TrachPhone recorded by study specific questionnaire, At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)|Patient preference, % of patients (participants that were assigned to Arm 2) recorded by study specific questionnaire, Upon discharge from the hospital (on average after 3 weeks)|Nurse and therapy team feedback, Staff impression and preference measured by nurse survey, Upon discharge of the last participant, on average after 1 year|Nursing time regarding device use, Minutes per day spent on device handling, recorded by nurse diary keeping, 3-day collection, At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)|Adherence to use of devices, Hours of use of each humidification method, recorded by study specific questionnaire, At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)|Patient communication, Communication by Therapy Outcome Measure for Voice Impairment (TOMS, score 0-5, higher score meaning no impairment), At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)|Voice Quality, Patient reported, for participants speaking, through study specific questionnaire, At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)|Patient mobility, Staff perception of patient mobility and ease of transportation, measured though study specific questionnaires and nurse survey, Upon discharge of the last participant, on average after 1 year|Oxygen needs, Weaning of oxygen time needed measured by peripheral oxygen saturation (%) recorded in patient charts. Only for monitoring reasons., At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge|Adverse Events, Any incidents reported throughout study duration, Through study completion, an average of 1 year