Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
22 participants
INTERVENTIONAL
2025-02-05
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients
NCT01976819
Hospital Acquired Pneumonia in Temporary Tracheostomy
NCT05418517
Tracheal Exposure Without Tracheostomy Completion in Trans-oral Robotic Oncologic Surgery
NCT06857396
Clinical Feasibility of New Tracheoesophageal Puncture Set
NCT01045057
Lymphedema Treatment in Head and Neck Cancer Patients
NCT04276454
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1 - HME
24/7 use of TrachPhone HME for the entirety of study
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.
Arm 2 - EH
24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation.
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.
External Humidifier (Usual Care)
Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
External Humidifier (Usual Care)
Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Self-ventilating via a tracheostomy tube, independent of cuff status
* 18 years or older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Barts & The London NHS Trust
OTHER
Atos Medical AB
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amanda Thomas, Dr
Role: PRINCIPAL_INVESTIGATOR
The Royal London Hospital, Barts Health NHS Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Royal London Hospital, Barts Health NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TrachPhone
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.