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NCT Number: NCT06897319

High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients

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.

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Key information

Conditions

Tracheostomized Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location contact

William Poncin

CONTACT

[email protected]

+3227641111

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (≥18 years old)
  • Tracheostomized patients
  • Patients requiring routine tracheal suctioning and already using HFT overnight

Exclusion criteria

  • Insufficient secretions for analysis
  • Cognitive impairment or confusion

Treatment and study plan

High-Flow Tracheal Therapy

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dyspnea (modified Borg scale)

    Time frame: Measured two times: at baseline and after 4 hours

    The modified Borg Scale (from 0 : no dyspnea; to 10 : maximal dyspnea) will be used

  2. Patient Comfort (Visual Analog Scale - VAS)

    Time frame: Measured two times: at baseline and after 4 hours

    The VAS (from 0 : extremely comfortable; to 10 : extremely uncomfortable) will be used

  3. Secretion Appearance (Murray Scale)

    Time frame: Measured two times: at baseline and after 4 hours

    The Murray scale define the following secretion appearance:

    • Mucoid
    • Mucopurulent
    • Purulent

  4. Viscoelastic modulus (G*)

    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 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.

  5. Damping ratio (tan δ)

    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.

    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.

  6. Critical strain (γc)

    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 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.

Study contacts

Contact information is provided by the study sponsor or research team.

William Poncin, PhD

CONTACT

[email protected]

+3227641111

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Impact of High-Flow Tracheal Therapy on the Rheological Properties of Tracheobronchial Secretions in Tracheostomized Patients: A Randomized Crossover Study.

Acronym: TRACH2O

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2025
Registry last updated
Apr 27, 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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