Tracheostomized Patients
Conditions
Brief 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. 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.
Interventions
DEVICEHigh-Flow Tracheal Therapy
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.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Critical stress (σc) | 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
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea (modified Borg scale) | Measured two times: at baseline and after 4 hours | The modified Borg Scale (from 0 : no dyspnea; to 10 : maximal dyspnea) will be used |
| Patient Comfort (Visual Analog Scale - VAS) | Measured two times: at baseline and after 4 hours | The VAS (from 0 : extremely comfortable; to 10 : extremely uncomfortable) will be used |
| Secretion Appearance (Murray Scale) | Measured two times: at baseline and after 4 hours | The Murray scale define the following secretion appearance: * Mucoid * Mucopurulent * Purulent |
| Viscoelastic modulus (G*) | 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. |
| Damping ratio (tan δ) | 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. |
| Critical strain (γc) | 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. |
Countries
Belgium
Contacts
CONTACTWilliam Poncin, PhD
PRINCIPAL_INVESTIGATORWilliam Poncin, PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Outcome results
None listed