Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes (Wean-Trach)

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

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.

Study Overview

• Status: Completed
• Conditions: Weaning Failure; Mechanical Ventilation; Patient-centered Care

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• Netherlands
  • 's-Hertogenbosch, Netherlands
    • Jeroen Bosch Ziekenhuis
  • Arnhem, Netherlands
    • Rijnstate Ziekenhuis
  • Breda, Netherlands
    • Amphia Ziekenhuis
  • Capelle aan den IJssel, Netherlands
    • IJsselland Ziekenhuis
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
  • Eindhoven, Netherlands
    • Maxima Medisch Centrum
  • Geldrop, Netherlands
    • St Anna ziekenhuis
  • Haarlem, Netherlands
    • Spaarne Gasthuis
  • Rotterdam, Netherlands
    • Erasmus MC
  • Rotterdam, Netherlands
    • Franciscus Gasthuis & Vlietland
  • Rotterdam, Netherlands
    • Ikazia Ziekenhuis
  • The Hague, Netherlands
    • Haags Medisch Centrum Westeinde
  • Tilburg, Netherlands, 3038XT
    • Elizabeth-Tweesteden Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a tracheostomy invasively ventilated in the ICUs of one of the participating hospitals.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily dyspnea score during weaning	The severity of dyspnea during disconnection from mechanical ventilation	During repeated disconnection sessions in the first 28 days after initiation of weaning with tracheostomy, once daily an assessment is made using Visual Analog Scale for Dyspnea. (0-10). Higher scores indicate higher levels of dyspnea.
Daily presence of dyspnea during weaning	The severity of dyspnea during disconnection from mechanical ventilation; calculated as number of days with dyspnea, and percentage of weaning days with dyspnea.	During repeated disconnection sessions in the first 28 days after initiation of weaning with tracheostomy, once daily an assessment is made by asking communicative patients if they experience dyspnea.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life (HR-QoL)	The HR-QoL, as measured with the EQ5D-5L questionnaire. High scores indicate a high level of perceived problems.	3 months after ICU discharge
Health-related Quality of Life (HR-QoL)	The HR-QoL, as measured with the EQ-VAS (0-100). High scores indicate a high level of self-reported HR-QoL.	3 months after ICU discharge
Post-traumatic stress Disorder (PTSD)	The presence PTSD-related symptoms, as measured with the IES-6 questionnaire	3 months after ICU discharge
Anxiety and Depression	The presence of long-term symptoms of anxiety and/or depression as measured with the Hospital-related Anxiety and Depression Scale (HADS) questionnaire.	3 months after ICU discharge
Endotracheal suctioning	Number of endotracheal suctioning manoeuvres during the weaning phase	In the first 28 days after weaning initiation
Daily discomfort score during disconnection session	The severity of discomfort	During repeated disconnection sessions in the first 28 days after initiation of weaning with tracheostomy, once daily an assessment is made using Visual Analog Scale for Discomfort (0-10). Higher scores indicate higher levels of discomfort.
Weaning duration	The time between the first disconnection session with tracheostomy and weaning	From start weaning until separation attempt after tracheostomy placement until disconnection from the ventilator for ≥7 consecutive days, or ICU discharge, whichever comes first
Mortality	28-day, ICU- and in-hospital mortality	From inclusion until 90 days after ICU discharge
Duration of tracheostomy in situ		Within 90 days after tracheostomy placement

Collaborators and Investigators

• Sponsor: Henrik Endeman
• Collaborators: Franciscus &Vlietland
• Investigators: Principal Investigator: Evert-Jan Wils, MD PhD, Franciscus Gasthuis & Vlietland; Study Director: Henrik Endeman, MD PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: W23.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No