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Enrolling by Invitation

NCT Number: NCT06487104

Use of TrachPhone in Tracheostomized Patients

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.

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Key information

Conditions

Tracheostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal London Hospital, Barts Health NHS Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TrachPhone HME

Device

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)

Device

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

Primary outcomes

  1. Number of suctioning per day

    Time frame: 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 outcomes

  1. Time needed for suctioning

    Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)

    Minutes per day of suctioning

  2. Quality of secretion

    Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)

    Amount and color of secretion

  3. Quality of Life by EQ-5D-5L

    Time frame: 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

  4. Use of TrachPhone

    Time frame: 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

  5. Patient preference

    Time frame: Upon discharge from the hospital (on average after 3 weeks)

    % of patients (participants that were assigned to Arm 2) recorded by study specific questionnaire

  6. Nurse and therapy team feedback

    Time frame: Upon discharge of the last participant, on average after 1 year

    Staff impression and preference measured by nurse survey

  7. Nursing time regarding device use

    Time frame: 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

  8. Adherence to use of devices

    Time frame: 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

  9. Patient communication

    Time frame: 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)

  10. Voice Quality

    Time frame: 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

  11. Patient mobility

    Time frame: 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

  12. Oxygen needs

    Time frame: 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.

  13. Adverse Events

    Time frame: Through study completion, an average of 1 year

    Any incidents reported throughout study duration

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Collaborators

  • Barts & The London NHS Trust

Registry information

Official study title

Safety, Feasibility, and Impact on Pulmonary Secretion Management Comparing the Use of TrachPhone and External Humidifier After Tracheostomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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