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

NCT05906888 | Completed

• 1 other identifier: W23.001
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 13

Brief 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

Mechanical Ventilation; Patient-centered Care; Weaning Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Weaning duration

  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

  From inclusion until 90 days after ICU discharge

• Health-related Quality of Life (HR-QoL)

  3 months after ICU discharge

• Health-related Quality of Life (HR-QoL)

  3 months after ICU discharge

• Post-traumatic stress Disorder (PTSD)

  3 months after ICU discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aged ≥18 years
• Scheduled to start weaning from iMV, as per clinical decision

You may not qualify if:

• 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

Sponsors & Collaborators

• Henrik Endeman: lead
• Franciscus &Vlietland: collaborator

Study Sites (13)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

IJsselland Ziekenhuis

Capelle aan den IJssel, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maxima Medisch Centrum

Eindhoven, Netherlands

Location

St Anna ziekenhuis

Geldrop, Netherlands

Location

Spaarne Gasthuis

Haarlem, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, Netherlands

Location

Haags Medisch Centrum Westeinde

The Hague, Netherlands

Location

Elizabeth-Tweesteden Ziekenhuis

Tilburg, 3038XT, Netherlands

Location

Study Officials

• Evert-Jan Wils, MD PhD

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

• Henrik Endeman, MD PhD

  Erasmus Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 18, 2023
• Study Start: May 8, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 19, 2025

Record last verified: 2024-11

Locations

NL (13)