Intratracheal Tracheostomy Sealing

Study design

Experimental animal study followed by a clinical feasibility study.

About the project

Tracheostomy is an artificial opening in the airways, commonly used during mechanical ventilation as an alternative to oral intubation. When the need for a tracheostomy has ceased, removal of the tracheostomy tube (known as decannulation) leaves a hole in the patient’s airways, with the consequence of loss of airway pressure. Following prolonged mechanical ventilation, the ability to pressurize the airways through coughing or the use of positive expiratory pressure therapy is crucial when rehabilitating lung tissue and regaining lung function. As a derived consequence of poor respiratory rehabilitation and insufficient lung function, the patient may need reinsertion of the tracheostomy tube, known as decannulation failure, with an incidence reported as high as up to 25%. Surprisingly, there are no current specific treatment options or intervention for this important and critical phase of the patient’s ventilator therapy.

The most frequent way to counteract the lack of airway pressure is to use simple occlusive dressings or bandages, however these are not airtight. Based on a patented design, we have developed a silicone prototype for intratracheal tracheostomy sealing. This allows the patient to regain normal voice and cough abilities immediately after decannulation, potentially solving the issue of air leakage and lowering the incidence of decannulation failure, reducing readmittance to the intensive care unit.


  • Development of a tracheostomy sealing tool for safety and tolerance study in pigs.
  • Clinical feasibility study in patients.
  • Clinical study comparing standard treatment versus the intratracheal tracheostomy sealing.


The project is carried our as a collaboration between Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital and Department of Anaesthesiology and Intensive Care, Aarhus University Hospital.

Project group

  • Rasmus Ellerup Kraghede, MD, PhD Student
  • J. Michael Hasenkam, MD, DMSc, Professor
  • Lone Nikolajsen, MD, DMSc, Professor
  • Stig Dyrskog, MD, PhD, Senior Consultant
  • Karen Juelsgaard Christiansen, RN
  • Michael Pedersen, MSc, PhD, Professor


Region Midtjyllands Sundhedsvidenskabelige Forskningsfond, Novo Nordisk Fonden (Pioneer Innovator Grant), and Købmand Hermann Salling Fonden.



Project period

Start: 1 June 2022
End: 1 June 2025


Project leader

Principal investigator & main supervisor