High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients (TRACH2O)

April 22, 2026 updated by: William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: 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.

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:

  • Mucoid
  • Mucopurulent
  • Purulent
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

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: William Poncin, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 15, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

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

No

Studies a U.S. FDA-regulated device product

No

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.

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