High-flow oxygen therapy for patients weaning off mechanical ventilation
Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning from Invasive Mechanical Ventilation
This study tests if high-flow oxygen therapy can help patients with tracheostomies breathe easier and clear mucus better while they are transitioning off mechanical ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06776939 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-flow tracheal oxygen (HFTO) on airway mucus viscosity and respiratory effort in patients with tracheostomies who are transitioning off invasive mechanical ventilation. The research aims to determine if HFTO can reduce sputum thickness and improve respiratory support during the weaning process compared to conventional oxygen therapy. By focusing on these physiological parameters, the study seeks to enhance patient outcomes during a critical phase of recovery from respiratory failure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently weaning from mechanical ventilation and have a tracheostomy.
Not a fit: Patients with longstanding tracheostomies or those with specific medical histories such as mucociliary or neuromuscular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the weaning process from mechanical ventilation, reducing respiratory complications and enhancing patient comfort.
How similar studies have performed: Previous studies have shown promising results with high-flow oxygen therapy in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Age ≥18 years * Weaning from mechanical ventilation with tracheostomy Exclusion Criteria: * 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: * 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.
Where this trial is running
Rotterdam
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Thijs Janssen Resident pulmonology, Critical Care researcher, MD
- Email: m.l.janssen@erasmusmc.nl
- Phone: 0107035142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.