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

NCT05906888 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2025-12-19

No results posted yet for this study

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

Sponsors & Collaborators

  • Franciscus &Vlietland

    collaborator OTHER

  • Henrik Endeman

    lead OTHER

Principal Investigators

  • Evert-Jan Wils, MD PhD · Franciscus Gasthuis & Vlietland

  • Henrik Endeman, MD PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906888 on ClinicalTrials.gov