Observational study on weaning patients with tracheostomy from mechanical ventilation

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

This study looks at how long it takes for patients with tracheostomy to stop using mechanical ventilation and how they feel during the process.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Erasmus Medical Center (other)
• Locations: 13 sites (Arnhem and 12 other locations)
• Trial ID: NCT05906888 on ClinicalTrials.gov

What this trial studies

This observational study aims to document the duration of weaning from invasive mechanical ventilation (IMV) in patients with tracheostomy, as well as to assess the prevalence and severity of dyspnea and discomfort experienced during this process. It will involve a multicenter cohort of critically ill patients who are scheduled to start weaning from IMV. The study will collect data on the frequency of endotracheal suctioning and the overall patient-centered outcomes related to their weaning experience.

Who should consider this trial

Good fit: Ideal candidates for this study are critically ill patients aged 18 years and older who are scheduled to begin weaning from invasive mechanical ventilation.

Not a fit: Patients who may not benefit from this study include those with neuromuscular diseases or chronic respiratory support needs, as well as those with tracheostomy for chronic airway obstruction.

Why it matters

Potential benefit: If successful, this study could improve the understanding of patient experiences during weaning, leading to better management strategies and enhanced quality of life for patients.

How similar studies have performed: While there is limited documentation on the specific weaning experiences of tracheostomized patients, similar observational studies have shown success in improving patient-centered outcomes in mechanical ventilation contexts.

Eligibility criteria

Inclusion Criteria:

* Aged ≥18 years
* Scheduled to start weaning from iMV, as per clinical decision

Exclusion Criteria:

* Deafness or Blindness
* Inability to speak or comprehend Dutch and English language
* Neuromuscular Disease
* Chronic positive pressure respiratory support at home (excluding night-time CPAP for sleep apnea)
* Support by Ventricular Assist Device or Extracorporeal life support (ECMO or ECCO2R) during tracheostomy-facilitated weaning phase.
* Tracheostomy primarily indicated for chronic upper airway obstruction or to secure airway patency due to persistent stupor/coma or swallowing disorder

Where this trial is running

Arnhem and 12 other locations

• Rijnstate Ziekenhuis — Arnhem, Netherlands (NOT_YET_RECRUITING)
• Amphia Ziekenhuis — Breda, Netherlands (NOT_YET_RECRUITING)
• IJsselland Ziekenhuis — Capelle Aan Den IJssel, Netherlands (RECRUITING)
• Jeroen Bosch Ziekenhuis — Den Bosch, Netherlands (RECRUITING)
• Haags Medisch Centrum Westeinde — Den Haag, Netherlands (RECRUITING)
• Catharina Ziekenhuis — Eindhoven, Netherlands (RECRUITING)
• Maxima Medisch Centrum — Eindhoven, Netherlands (RECRUITING)
• St Anna ziekenhuis — Geldrop, Netherlands (RECRUITING)
• Spaarne Gasthuis — Haarlem, Netherlands (RECRUITING)
• Erasmus MC — Rotterdam, Netherlands (RECRUITING)
• Franciscus Gasthuis & Vlietland — Rotterdam, Netherlands (RECRUITING)
• Ikazia Ziekenhuis — Rotterdam, Netherlands (RECRUITING)
• Elizabeth-Tweesteden Ziekenhuis — Tilburg, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Evert-Jan Wils, MD PhD — Franciscus Gasthuis & Vlietland
• Study coordinator: Matthijs Janssen

Conditions: Weaning Failure, Mechanical Ventilation, Patient-centered Care