High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients (TRACH2O)
Impact of High-Flow Tracheal Therapy on the Rheological Properties of Tracheobronchial Secretions in Tracheostomized Patients: A Randomized Crossover Study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: William Poncin, PhD
- Phone Number: +3227641111
- Email: william.poncin@uclouvain.be
Study Locations
-
-
Brussels Capital
-
Brussels, Brussels Capital, Belgium, 1200
- Cliniques Universitaires Saint-Luc
-
Contact:
- William Poncin
- Phone Number: +3227641111
- Email: william.poncin@uclouvain.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: HFT
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Measured three times: at baseline, after one hour, after 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
The VAS (from 0 : extremely comfortable; to 10 : extremely uncomfortable) will be used
|
Measured two times: at baseline and after 4 hours
|
|
Secretion Appearance (Murray Scale)
Time Frame: Measured two times: at baseline and after 4 hours
|
The Murray scale define the following secretion appearance:
|
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
|
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 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
|
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 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
|
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 three times: at baseline, after one hour, after 4 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: William Poncin, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TRACH2O
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.