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High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients

ConditionTracheostomized Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years old)

Tracheostomized patients

Patients requiring routine tracheal suctioning and already using HFT overnight

Disqualifiers

Insufficient secretions for analysis

Cognitive impairment or confusion

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: HFTExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Measured three times: at baseline, after one hour, after 4 hours

Secondary outcomes

1

Dyspnea (modified Borg scale)

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

Time frame
Measured two times: at baseline and after 4 hours
2

Patient Comfort (Visual Analog Scale - VAS)

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

Time frame
Measured two times: at baseline and after 4 hours
3

Secretion Appearance (Murray Scale)

The Murray scale define the following secretion appearance: * Mucoid * Mucopurulent * Purulent

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

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.

Time frame
Measured three times: at baseline, after one hour, after 4 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: