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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
22
Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients. The TrachPhone HME is an HME specifically designed for tracheostomy patients.
Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.
The Royal London Hospital, Barts Health NHS Trust
London, United Kingdom
Number of suctioning per day
Times per day suctioning is required
Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)
Time needed for suctioning
Minutes per day of suctioning
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Upon discharge from the hospital (on average after 3 weeks)
Nurse and therapy team feedback
Staff impression and preference measured by nurse survey
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Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge
Adverse Events
Any incidents reported throughout study duration
Time frame: Through study completion, an average of 1 year