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Completed

NCT Number: NCT05906888

Weaning 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.

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Key information

Conditions

Weaning Failure Mechanical Ventilation Patient-centered Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Daily dyspnea score during weaning

    Time frame: 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.

    The severity of dyspnea during disconnection from mechanical ventilation

  2. Daily presence of dyspnea during weaning

    Time frame: 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.

    The severity of dyspnea during disconnection from mechanical ventilation; calculated as number of days with dyspnea, and percentage of weaning days with dyspnea.

Secondary outcomes

  1. Weaning duration

    Time frame: From start weaning until separation attempt after tracheostomy placement until disconnection from the ventilator for ≥7 consecutive days, or ICU discharge, whichever comes first

    The time between the first disconnection session with tracheostomy and weaning

  2. Mortality

    Time frame: From inclusion until 90 days after ICU discharge

    28-day, ICU- and in-hospital mortality

  3. Health-related Quality of Life (HR-QoL)

    Time frame: 3 months after ICU discharge

    The HR-QoL, as measured with the EQ5D-5L questionnaire. High scores indicate a high level of perceived problems.

  4. Health-related Quality of Life (HR-QoL)

    Time frame: 3 months after ICU discharge

    The HR-QoL, as measured with the EQ-VAS (0-100). High scores indicate a high level of self-reported HR-QoL.

  5. Post-traumatic stress Disorder (PTSD)

    Time frame: 3 months after ICU discharge

    The presence PTSD-related symptoms, as measured with the IES-6 questionnaire

  6. Anxiety and Depression

    Time frame: 3 months after ICU discharge

    The presence of long-term symptoms of anxiety and/or depression as measured with the Hospital-related Anxiety and Depression Scale (HADS) questionnaire.

  7. Endotracheal suctioning

    Time frame: In the first 28 days after weaning initiation

    Number of endotracheal suctioning manoeuvres during the weaning phase

  8. Daily discomfort score during disconnection session

    Time frame: 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.

    The severity of discomfort

  9. Duration of tracheostomy in situ

    Time frame: Within 90 days after tracheostomy placement

Sponsors and collaborators

Lead sponsor

Henrik Endeman

Other

Collaborators

  • Franciscus &Vlietland

Registry information

Official study title

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

Acronym: Wean-Trach

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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