High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients

NCT06897319 | Not Yet Recruiting

• 1 other identifier: TRACH2O
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomized Patients

Outcome Measures

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.

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

Secondary Outcomes (6)

• Dyspnea (modified Borg scale)

  Measured two times: at baseline and after 4 hours

• Patient Comfort (Visual Analog Scale - VAS)

  Measured two times: at baseline and after 4 hours

• Secretion Appearance (Murray Scale)

  Measured two times: at baseline and after 4 hours

• Viscoelastic modulus (G*)

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

• Damping ratio (tan δ)

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

Study Arms (2)

HFT

EXPERIMENTAL

Device: High-Flow Tracheal Therapy

Control

NO INTERVENTION

Interventions

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.

HFT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years old)
• Tracheostomized patients
• Patients requiring routine tracheal suctioning and already using HFT overnight

You may not qualify if:

• Insufficient secretions for analysis
• Cognitive impairment or confusion

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Study Officials

• William Poncin, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Poncin, PhD

CONTACT

+3227641111; william.poncin@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 26, 2025
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

BE (1)