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Enrolling by invitation NCT06487104

Use of TrachPhone in Tracheostomized Patients

No phase Interventional Tracheostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TrachPhone HME, External Humidifier (Usual Care).
Who it may be relevant to
Registry conditions: Tracheostomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device TrachPhone HME
    Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients. The TrachPhone HME is an HME specifically designed for tracheostomy patients.
  • Device External Humidifier (Usual Care)
    Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.

Primary outcome measures

  • 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)]
Secondary outcome measures (12)
  • Time needed for suctioning [Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
  • Quality 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 [Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
  • Use of TrachPhone [Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
  • Patient preference [Time frame: Upon discharge from the hospital (on average after 3 weeks)]
  • Nurse and therapy team feedback [Time frame: Upon discharge of the last participant, on average after 1 year]
  • 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)]
  • 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)]
  • Patient communication [Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
  • Voice Quality [Time frame: At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)]
  • Patient mobility [Time frame: Upon discharge of the last participant, on average after 1 year]
  • Oxygen needs [Time frame: At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • The Royal London Hospital, Barts Health NHS Trust — London

Identifiers

NCT: NCT06487104 · TrachPhone

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗