Weaning From Mechanical VentilationPIONEERNCT06776939
Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning From Invasive Mechanical Ventilation
A study testing Oxygen therapy in people with Weaning From Mechanical Ventilation and Tracheostomy Weaning, run by Henrik Endeman at 1 site in Netherlands.
Trial summary
Rationale: Tracheostomized patients weaning from mechanical ventilation are at risk for dryness of airway mucosa and sputum accumulation during disconnection from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation, Tracheostomy Weaning, Respiratory Failure
- What is being tested?
- Oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Dec 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Weaning from mechanical ventilation with tracheostomy
Who cannot join
- Longstanding tracheostomy, defined as tracheostomy being present prior to current hospital admission
- Tracheostomy primarily indicated for chronic upper airway obstruction or to secure airway patency due to persistent stupor/coma
- Chronic positive pressure respiratory support at home (excluding night-time continuous positive airway pressure for sleep apnea)
- Mucociliary disease in medical history (e.g. cystic fibrosis, pulmonary ciliary dyskinesia)
- Neuromuscular disease in medical history (excluding ICU-acquired weakness)
- Contra-indication placement oesophageal balloon for measurement of PES, such as:
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- Fractures in mandibular, orbital or ethmoid bone or skull base
- Esophageal varices or surgery in medical history
- Severe bleeding disorders
- Hemoptysis in 72 hours prior to the first disconnection session. Clinically relevant hemoptysis is defined as hemoptysis requiring tracheal/endobronchial or radiologic intervention, or administration of pro-coagulating drugs such as tranexamic acid.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thijs Janssen Resident pulmonology, Critical Care researcher, MD contact
Henrik Endeman Intensivist, Assistant Professor Intensive Care, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, 3015
Thijs Janssen, MD, 010-7035142, m.l.janssen@erasmusmc.nl
About this study
Rationale: Tracheostomized patients weaning from mechanical ventilation are at risk for dryness of airway mucosa and sputum accumulation during disconnection from mechanical ventilation. High-flow tracheal oxygen (HFTO) is being used as supportive therapy during disconnection sessions in tracheostomized patients weaning from invasive mechanical ventilation (IMV) to limit dryness while maintaining oxygenation. We recently summarized the studies comparing physiological effects HFTO as compared to other interfaces, collectively referred to as conventional oxygen therapy (COT), in a systematic review and identified areas of lacking knowledge: effect on sputum viscoelasticity, respiratory effort early in the weaning process and dyspnea sensation. We hypothesize that HFTO, compared to COT, decreases viscoelasticity of the sputum and provides respiratory support during weaning. This may improve weaning by facilitating clearance of airway mucus, preventing respiratory failure, and providing comfort by decreasing dyspnea.
Objective: To determine the physiological effect of HFTO compared to COT on sputum viscoelasticity, respiratory effort and dyspnoea.
Read more
Study design: Pilot study with randomized crossover design, single-center. Study population: Twenty adult patients weaning from mechanical ventilation with tracheostomy.
Intervention (if applicable): Crossover with COT and HFTO during two days in the weaning phase.
Main study parameters/endpoints: Primary endpoint: sputum viscoelasticity measured by rheology during long disconnection sessions in the final phase of weaning. Secondary endpoints: respiratory effect measured by swings in esophageal pressure (PES) and prevalence and severity of dyspnoea sensation by visual analogue scale (VAS).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study compares two therapeutic modalities both used in clinical care without side-effects or complications. Study procedures and measurements consist of standard clinical procedures that are performed daily in clinical setting with negligible risk of deterioration for the patient. During weaning with HFTO sputum clearance might be more easy for the patient and respiratory effort might decrease, both are assumed to be beneficial for the weaning process of the patient.
- Being tested
- Oxygen therapy
- Keywords
- weaning from mechanical ventilation, tracheostomy, high flow oxygen, airway mucus, respiratory effort, dyspnea
- Medical subject headings
- Respiratory Insufficiency, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen therapyDevice
All patients are subject to both oxygen therapy groups in this randomized cross-over study. Study measurements are performed during several different disconnection sessions. Disconnection sessions can either be short (<90 min) or long (12 hours). Both short and long disconnection sessions are performed twice; once with conventional oxygen, and once with high-flow tracheal oxygen as respiratory support.
| Study group | Role | What they receive |
|---|---|---|
| First high-flow tracheal oxygen, then conventional oxygen therapy | Active comparator | The disconnection sessions on the days with study measurements are started with high-flow tracheal oxygen, and the second disconnection session is supported with conventional oxygen therapy. Conventional oxygen therapy is provided using a heat-moisture exchanger. Receives: Device: Oxygen therapy |
| First conventional oxygen therapy, then high-flow tracheal oxygen | Active comparator | The disconnection sessions on the days with study measurements are started with conventional oxygen therapy, and the second disconnection session is supported with high-flow tracheal oxygen. Conventional oxygen therapy is provided using a heat-moisture exchanger. Receives: Device: Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum viscoelasticity
During disconnection from the ventilator patients do not breathe actively heated and humidified gas mixtures. During disconnection from the ventilator the airway mucus thickens. This thickening can be quantified by measuring visco-elasticity and at the end of the disconnection sessions. The change in visco-elasticity between the start and end of the disconnection session will be compared within patients between disconnection sessions with HME and HFTO. Hence, the primary end-point is the change in sputum viscoelasticity from baseline to the end of the long disconnection sessions (≥12 hours). Viscoelastic (G*) is made up of elasticity (G') and viscosity (G'') of mucus at a 5% strain rate (or linear viscoelastic region, which reflects the small deformation regime) and the critical stress (σ critical)· and strain (y critical) of mucus, which reflect the behavior of mucus under high amounts of shear stress and thus the large deformation regime.
Measured: The 12-hour disconnection session
Secondary outcomes (4)
Sputum visco-elasiticity
The difference between COT and HFTO in change in sputum viscoelasticity from baseline to the end (after 10-90 min) of the early disconnection session
Measured: The short disconnection session (<90 minutes)
Dyspnea presence
The presence of self-reported dyspnea sensation during early (<90 min) and late (12 hour) disconnection sessions. Presence of self-reported dyspnea and discomfort is evaluated by asking patients.
Measured: At early (<90 min) and late (12 hour) disconnection sessions
Respiratory effort
The difference in respiratory effort between conventional oxygen therapy and high-flow oxygen therapy during early disconnection sessions measured by median esophageal pressure swing and pressure time product during the early disconnection session.
Measured: The short disconnection session (<90 minutes)
Dyspnea severity
The severity of self-reported dyspnea sensation during early (<90 min) and late (12 hour) disconnection sessions. Severity of self-reported dyspnea is evaluated using a dyspnea visual-analog scale (D-VAS)
Measured: early (<90 min) and late (12 hour) disconnection sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning From Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Endeman
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor-investigator, Henrik Endeman, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776939
- Sponsor's protocol ID
- MEC-2024-0468
- Other IDs
- NL87502.078.24
- Acronym
- PIONEER
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided