Use of TrachPhone in Tracheostomized Patients
- Conditions
- Tracheostomy
- Interventions
- Device: TrachPhone HMEDevice: External Humidifier (Usual Care)
- Registration Number
- NCT06487104
- Lead Sponsor
- Atos Medical AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 22
- Tracheostomy patient outside critical care
- Self-ventilating via a tracheostomy tube, independent of cuff status
- 18 years or older
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 - EH External Humidifier (Usual Care) 24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation. Arm 1 - HME TrachPhone HME 24/7 use of TrachPhone HME for the entirety of study Arm 2 - EH TrachPhone HME 24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Time needed for suctioning At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks) Minutes per day of suctioning
Quality of Life by EQ-5D-5L At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks) 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
Patient preference Upon discharge from the hospital (on average after 3 weeks) % of patients (participants that were assigned to Arm 2) recorded by study specific questionnaire
Use of TrachPhone At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks) % of patients using TrachPhone/tolerating TrachPhone recorded by study specific questionnaire
Quality of secretion At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks) Amount and color of secretion
Nursing time regarding device use At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks) Minutes per day spent on device handling, recorded by nurse diary keeping, 3-day collection
Adherence to use of devices At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks) Hours of use of each humidification method, recorded by study specific questionnaire
Patient communication At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks) Communication by Therapy Outcome Measure for Voice Impairment (TOMS, score 0-5, higher score meaning no impairment)
Oxygen needs At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge Weaning of oxygen time needed measured by peripheral oxygen saturation (%) recorded in patient charts. Only for monitoring reasons.
Adverse Events Through study completion, an average of 1 year Any incidents reported throughout study duration
Voice Quality At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks) Patient reported, for participants speaking, through study specific questionnaire
Patient mobility Upon discharge of the last participant, on average after 1 year Staff perception of patient mobility and ease of transportation, measured though study specific questionnaires and nurse survey
Nurse and therapy team feedback Upon discharge of the last participant, on average after 1 year Staff impression and preference measured by nurse survey
Trial Locations
- Locations (1)
The Royal London Hospital, Barts Health NHS Trust
🇬🇧London, United Kingdom