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

Last updated: November 8, 2024
Sponsor: Henrik Endeman
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05906888
W23.001
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥18 years

  • Scheduled to start weaning from iMV, as per clinical decision

Exclusion

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 forsleep 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 secureairway patency due to persistent stupor/coma or swallowing disorder

Study Design

Total Participants: 150
Study Start date:
May 08, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Rijnstate Ziekenhuis

    Arnhem,
    Netherlands

    Site Not Available

  • Amphia Ziekenhuis

    Breda,
    Netherlands

    Site Not Available

  • IJsselland Ziekenhuis

    Capelle Aan Den IJssel,
    Netherlands

    Active - Recruiting

  • Reinier de Graaf Gasthuis

    Delft,
    Netherlands

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    Den Bosch,
    Netherlands

    Active - Recruiting

  • Haags Medisch Centrum Westeinde

    Den Haag,
    Netherlands

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Maxima Medisch Centrum

    Eindhoven,
    Netherlands

    Active - Recruiting

  • St Anna ziekenhuis

    Geldrop,
    Netherlands

    Active - Recruiting

  • Spaarne Gasthuis

    Haarlem,
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Franciscus Gasthuis & Vlietland

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Ikazia Ziekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Elizabeth-Tweesteden Ziekenhuis

    Tilburg, 3038XT
    Netherlands

    Active - Recruiting

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