Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes
NCT ID: NCT05906888
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
156 participants
OBSERVATIONAL
2023-05-08
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled to start weaning from iMV, as per clinical decision
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Franciscus &Vlietland
OTHER
Henrik Endeman
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Henrik Endeman
Sponsor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Evert-Jan Wils, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Franciscus Gasthuis & Vlietland
Henrik Endeman, MD PhD
Role: STUDY_DIRECTOR
Erasmus Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
IJsselland Ziekenhuis
Capelle aan den IJssel, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
St Anna ziekenhuis
Geldrop, , Netherlands
Spaarne Gasthuis
Haarlem, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Haags Medisch Centrum Westeinde
The Hague, , Netherlands
Elizabeth-Tweesteden Ziekenhuis
Tilburg, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W23.001
Identifier Type: -
Identifier Source: org_study_id