NCT05906888

Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes

Invasive Mechanical Ventilation With Tracheostomy - an Observational Study on Patient-centered Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Henrik Endeman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: It is largely undocumented how long it takes to wean from invasive mechanical ventilation (IMV) with tracheostomy and to what extend these patients suffer from dyspnea or discomfort and how often sputum retention occurs requiring burdensome endotracheal suctioning. In patients undergoing invasive mechanical ventilation via endotracheal tube, dyspnea is prevalent and associated with poorer quality of life and more symptoms of post-traumatic stress disorder (PTSD) Objectives: The present study aims to assess the duration of the weaning period, and the prevalence and severity of dyspnea and discomfort in patients with tracheostomy-facilitated weaning. Study design: Prospective observational multicenter cohort study. Study population: Tracheostomized critically ill patients weaning from IMV. Main study parameters/endpoints: Prevalence and severity of dyspnea and discomfort during weaning, duration of weaning with tracheostomy, frequency of endotracheal suctioning, time with tracheostomy, clinical outcomes, and mortality rates. Long term outcomes are the prevalence quality of life, PTSD, anxiety and fear.

Conditions

• Weaning Failure
• Mechanical Ventilation
• Patient-centered Care

Timeline

• Start date: 2023-05-08
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2023-06-18
• Last updated: 2025-12-19

Locations

13 sites across 1 country: Netherlands