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Search / Trial NCT05906888

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

Launched by HENRIK ENDEMAN · Jun 13, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "Weaning With Tracheostomy," is studying how long it takes for patients with a tracheostomy (a tube placed in the neck to help with breathing) to stop using a machine that helps them breathe, known as invasive mechanical ventilation (IMV). The researchers want to learn about how much discomfort or shortness of breath these patients experience during this process, how often they need suctioning (a procedure to clear mucus from the airways), and the overall impact on their quality of life, including feelings of anxiety or post-traumatic stress.

To be eligible for this study, participants must be at least 18 years old and scheduled to start the weaning process from IMV. However, those who have certain conditions, such as severe hearing or vision issues, or who cannot speak or understand Dutch or English, won't be included. If you decide to participate, you can expect to be monitored for your breathing comfort and other health outcomes during the weaning period. This study aims to gather important information that could help improve care for patients undergoing this challenging transition.

Gender

ALL

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

About Henrik Endeman

Henrik Endeman is a dedicated clinical trial sponsor committed to advancing medical research through innovative and ethical study designs. With a strong focus on patient safety and regulatory compliance, Endeman fosters collaboration among researchers, healthcare professionals, and stakeholders to facilitate the development of groundbreaking therapies. Leveraging extensive expertise in clinical operations and strategic planning, he aims to streamline trial processes and enhance data integrity, ultimately contributing to the improvement of health outcomes and the acceleration of drug development.

Locations

Eindhoven, , Netherlands

Arnhem, , Netherlands

Den Bosch, , Netherlands

Breda, , Netherlands

Capelle Aan Den Ijssel, , Netherlands

Rotterdam, , Netherlands

Delft, , Netherlands

Eindhoven, , Netherlands

Geldrop, , Netherlands

Rotterdam, , Netherlands

Haarlem, , Netherlands

Rotterdam, , Netherlands

Rotterdam, , Netherlands

Den Haag, , Netherlands

Tilburg, , Netherlands

Patients applied

0 patients applied

Trial Officials

Evert-Jan Wils, MD PhD

Principal Investigator

Franciscus Gasthuis & Vlietland

Henrik Endeman, MD PhD

Study Director

Erasmus Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported