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Search / Trial NCT06776939

Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning from Invasive Mechanical Ventilation

Launched by HENRIK ENDEMAN · Jan 10, 2025

Trial Information

Current as of September 08, 2025

Recruiting

Keywords

Weaning From Mechanical Ventilation Tracheostomy High Flow Oxygen Airway Mucus Respiratory Effort Dyspnea

ClinConnect Summary

This clinical trial is studying the effects of high-flow tracheal oxygen (HFTO) on patients who are being weaned off mechanical ventilation and have a tracheostomy. When patients disconnect from mechanical ventilation, they may experience dryness in their airways and have difficulty clearing mucus, which can make breathing harder. The researchers want to see if using HFTO helps make the mucus easier to clear and reduces the effort needed to breathe, compared to standard oxygen therapy. This could help patients feel more comfortable and improve their chances of successfully weaning off the ventilator.

To be eligible for this study, participants must be at least 18 years old and currently in the process of weaning from mechanical ventilation with a tracheostomy. Patients who have had a long-term tracheostomy or certain medical conditions, like specific lung diseases, will not be included. During the trial, participants will try both HFTO and standard oxygen therapy over two days to see how each method affects their mucus and breathing efforts. Importantly, the procedures involved in this study are routine and carry minimal risk. Overall, this trial aims to improve the care and comfort of patients transitioning off mechanical ventilation.

Gender

ALL

Eligibility 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.

About Henrik Endeman

Henrik Endeman is a dedicated clinical trial sponsor committed to advancing medical research through innovative and ethical study designs. With a strong focus on patient safety and regulatory compliance, Endeman fosters collaboration among researchers, healthcare professionals, and stakeholders to facilitate the development of groundbreaking therapies. Leveraging extensive expertise in clinical operations and strategic planning, he aims to streamline trial processes and enhance data integrity, ultimately contributing to the improvement of health outcomes and the acceleration of drug development.

Locations

Rotterdam, , Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported