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Not yet recruiting NCT06897319

High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients

No phase Interventional Tracheostomized Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Flow Tracheal Therapy.
Who it may be relevant to
Registry conditions: Tracheostomized Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Device High-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.

Primary outcome measures

  • Critical stress (σc) [Time frame: Measured three times: at baseline, after one hour, after 4 hours]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

Belgium · 1 center
  • Cliniques universitaires Saint-Luc — Brussels

Identifiers

NCT: NCT06897319 · TRACH2O

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗