Tracheostomized PatientsTRACH2ONCT06897319
High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients
A study testing High-Flow Tracheal Therapy in people with Tracheostomized Patients, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This monocentric, randomized crossover study aims to assess the impact of high-flow tracheal therapy (HFT) on the rheological properties of tracheobronchopulmonary secretions in tracheostomized patients. The primary objective is to compare the viscoelastic characteristics of secretions collected with and without HFT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomized Patients
- What is being tested?
- High-Flow Tracheal Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jun 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old)
- Tracheostomized patients
- Patients requiring routine tracheal suctioning and already using HFT overnight
Who cannot join
- Insufficient secretions for analysis
- Cognitive impairment or confusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
William Poncin, +3227641111, william.poncin@uclouvain.be
About this study
Official title: Impact of High-Flow Tracheal Therapy on the Rheological Properties of Tracheobronchial Secretions in Tracheostomized Patients: A Randomized Crossover Study.
This monocentric, randomized crossover study aims to assess the impact of high-flow tracheal therapy (HFT) on the rheological properties of tracheobronchopulmonary secretions in tracheostomized patients. The primary objective is to compare the viscoelastic characteristics of secretions collected with and without HFT. Secondary objectives include evaluating the effects of HFT on dyspnea, patient comfort, and secretion appearance. The study will take place at Cliniques Universitaires Saint-Luc, with adult tracheostomized patients undergoing standard care.
- Conditions
- Tracheostomized Patients
- Being tested
- High-Flow Tracheal Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Tracheal TherapyDevice
Device: Airvo 2 (Fisher \& Paykel Healthcare) Settings: Flow rate start at 40L/min and will be adapted according to tolerance; temperature aimed at 37°C or 34°C according to tolerance, FiO₂ set (if needed) according to SpO2 target values.
| Study group | Role | What they receive |
|---|---|---|
| HFT | Experimental | Not described Receives: Device: High-Flow Tracheal Therapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical stress (σc)
The rheological properties measured using Rheomuco (Rheonova) will be sampled during a suctioning procedure.
The critical stress σc = G*(γc).γc, where G*(γc) is the viscoelastic modulus measured at the critical strain, is the measured stress at which this transition occurs.
See the description of the other rheological outcomes in the secondary outcomes.
Measured: Measured three times: at baseline, after one hour, after 4 hours
Secondary outcomes (6)
Dyspnea (modified Borg scale)
The modified Borg Scale (from 0 : no dyspnea; to 10 : maximal dyspnea) will be used
Measured: Measured two times: at baseline and after 4 hours
Patient Comfort (Visual Analog Scale - VAS)
The VAS (from 0 : extremely comfortable; to 10 : extremely uncomfortable) will be used
Measured: Measured two times: at baseline and after 4 hours
Secretion Appearance (Murray Scale)
The Murray scale define the following secretion appearance:
- Mucoid
- Mucopurulent
- Purulent
Measured: Measured two times: at baseline and after 4 hours
Viscoelastic modulus (G*)
The rheological properties measured using Rheomuco (Rheonova) will be sampled during a suctioning procedure.
The ratio of the stress to the strain, the viscoelastic modulus G* , describes the molecular network force in response to shear.
In viscoelastic materials, the viscous dissipation shifts in time the stress response to the imposed strain, which is quantified by the damping ratio tan δ. Both G* and tan δ provide the viscous and elastic moduli, G' and G''.
See the description of the other rheological outcomes in the secondary outcomes.
Measured: Measured three times: at baseline, after one hour, after 4 hours
Damping ratio (tan δ)
The rheological properties measured using Rheomuco (Rheonova) will be sampled during a suctioning procedure.
At given deformation, a damping ratio above 1 would describe a predominantly viscous material (G'' > G'), i.e. that behaves like a liquid, whereas a damping ratio below 1 denotes a predominantly elastic material (G' > G''), that exhibits a solid-like behavior.
Measured: Measured three times: at baseline, after one hour, after 4 hours
Critical strain (γc)
The rheological properties measured using Rheomuco (Rheonova) will be sampled during a suctioning procedure.
The viscoelastic characteristics are measured at increasing strains, ranging from about 1 % to about 10000 %. At a critical strain value, γc, typically around or above 1000 % for sputa, the G' and G'' curves cross over (the damping ratio overcomes 1). Beyond this critical point, the sample becomes predominantly viscous over elastic (fluid-like) under strain and starts to flow.
See the description of the other rheological outcomes in the secondary outcomes.
Measured: Measured three times: at baseline, after one hour, after 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start20 Jun 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomized PatientsStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- William Poncin, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897319
- Sponsor's protocol ID
- TRACH2O
- Acronym
- TRACH2O
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High-Flow Tracheal Therapy on the Rheological Properties of Tracheobronchial Secretions in Tracheostomized Patients: A Randomized Crossover Study.
- ClinicalTrials.gov ID
- NCT06897319
- Acronym / sponsor ID
- TRACH2O / TRACH2O
- Conditions
- Tracheostomized Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This monocentric, randomized crossover study aims to assess the impact of high-flow tracheal therapy (HFT) on the rheological properties of tracheobronchopulmonary secretions in tracheostomized patients. The primary objective is to compare the viscoelastic characteristics of secretions collected with and without HFT. Secondary objectives include evaluating the effects of HFT on dyspnea, patient comfort, and secretion appearance. The study will take place at Cliniques Universitaires Saint-Luc, with adult tracheostomized patients undergoing standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFT | Experimental | Device: High-Flow Tracheal Therapy |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years old)
- Tracheostomized patients
- Patients requiring routine tracheal suctioning and already using HFT overnight
Key exclusion criteria (2 listed)
- Insufficient secretions for analysis
- Cognitive impairment or confusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Flow Tracheal TherapyDevice: Airvo 2 (Fisher \& Paykel Healthcare) Settings: Flow rate start at 40L/min and will be adapted according to tolerance; temperature aimed at 37°C or 34°C according to tolerance, FiO₂ set (if needed) according to SpO2 target values. | Device | HFT |
Primary outcome
Critical stress (σc)
Time frame: Measured three times: at baseline, after one hour, after 4 hours
The rheological properties measured using Rheomuco (Rheonova) will be sampled during a suctioning procedure. The critical stress σc = G*(γc).γc, where G*(γc) is the viscoelastic modulus measured at the critical strain, is the measured stress at which this transition occurs. See the description of the other rheological outcomes in the secondary outcomes.
6 secondary outcomes
Dyspnea (modified Borg scale)
Time frame: Measured two times: at baseline and after 4 hours
Patient Comfort (Visual Analog Scale - VAS)
Time frame: Measured two times: at baseline and after 4 hours
Secretion Appearance (Murray Scale)
Time frame: Measured two times: at baseline and after 4 hours
Viscoelastic modulus (G*)
Time frame: Measured three times: at baseline, after one hour, after 4 hours
Damping ratio (tan δ)
Time frame: Measured three times: at baseline, after one hour, after 4 hours
Critical strain (γc)
Time frame: Measured three times: at baseline, after one hour, after 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Related trials for Tracheostomized Patients
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
Enrolling by invitationObservational study
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
Recruiting
Nasal Airflow to Modulate Dyspnea in Tracheostomized Patients
Ventilated Patients
Recruiting
Incremental Dead Space Versus Capping Trial Before Tracheostomy Decannulation
Tracheostomy, Prolonged Mechanical Ventilation
Not yet recruitingPhase 1/2
Randomized Clinical Trial of the Application of TrachPhone HME and the Impact on Patient Satisfaction for Tracheostomized Head and Neck Cancer Patients
Patient Satisfaction, Pulmonary Rehabilitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Poncin, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Flow Tracheal Therapy in people with Tracheostomized Patients, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Poncin, PhD (+3227641111, william.poncin@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical stress (σc) (time frame: Measured three times: at baseline, after one hour, after 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.