Weaning FailureWean-TrachNCT05906888
Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes
An observational study of Weaning Failure and Mechanical Ventilation, run by Henrik Endeman at 13 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Mechanical Ventilation, Patient-centered Care
- How many people
- 156 participants
- Where
- 13 sitesNetherlands
- Study dates
- 8 May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a tracheostomy invasively ventilated in the ICUs of one of the participating hospitals.
Who may be able to join
- Aged ≥18 years
- Scheduled to start weaning from iMV, as per clinical decision
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Rijnstate Ziekenhuis
Arnhem
Amphia Ziekenhuis
Breda
IJsselland Ziekenhuis
Capelle aan den IJssel
Catharina Ziekenhuis
Eindhoven
Maxima Medisch Centrum
Eindhoven
St Anna ziekenhuis
Geldrop
Spaarne Gasthuis
Haarlem
Erasmus MC
Rotterdam
Franciscus Gasthuis & Vlietland
Rotterdam
Ikazia Ziekenhuis
Rotterdam
Haags Medisch Centrum Westeinde
The Hague
Elizabeth-Tweesteden Ziekenhuis
Tilburg, 3038XT
About this study
Official title: 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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily dyspnea score during weaning
The severity of dyspnea during disconnection from mechanical ventilation
Measured: 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.
Measured: 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
The time between the first disconnection session with tracheostomy and weaning
Measured: 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
Measured: From inclusion until 90 days after ICU discharge
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.
Measured: 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.
Measured: 3 months after ICU discharge
Post-traumatic stress Disorder (PTSD)
The presence PTSD-related symptoms, as measured with the IES-6 questionnaire
Measured: 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.
Measured: 3 months after ICU discharge
Endotracheal suctioning
Number of endotracheal suctioning manoeuvres during the weaning phase
Measured: In the first 28 days after weaning initiation
Daily discomfort score during disconnection session
The severity of discomfort
Measured: 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.
Duration of tracheostomy in situ
Measured: Within 90 days after tracheostomy placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start8 May 2023
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Endeman
- Sponsor type
- University, hospital or other
- Collaborators
- Franciscus &Vlietland
- Responsible party
- Sponsor-investigator, Henrik Endeman, Erasmus Medical Center
- Investigators
- Evert-Jan Wils, MD PhD, Principal investigator, Franciscus Gasthuis & VlietlandHenrik Endeman, MD PhD, Study director, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906888
- Sponsor's protocol ID
- W23.001
- Acronym
- Wean-Trach
- Status last verified
- Nov 2024
- First submitted
- 10 May 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Mechanical Ventilation With Tracheostomy - an Observational Study on Patient-centered Outcomes
- ClinicalTrials.gov ID
- NCT05906888
- Acronym / sponsor ID
- Wean-Trach / W23.001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Henrik EndemanUniversity, hospital or other
- Collaborators
- Franciscus &Vlietland
- Study start
- 8 May 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a tracheostomy invasively ventilated in the ICUs of one of the participating hospitals.
Key inclusion criteria (2 listed)
- Aged ≥18 years
- Scheduled to start weaning from iMV, as per clinical decision
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
9 secondary outcomes
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
Mortality
Time frame: From inclusion until 90 days after ICU discharge
Health-related Quality of Life (HR-QoL)
Time frame: 3 months after ICU discharge
Health-related Quality of Life (HR-QoL)
Time frame: 3 months after ICU discharge
Post-traumatic stress Disorder (PTSD)
Time frame: 3 months after ICU discharge
Anxiety and Depression
Time frame: 3 months after ICU discharge
Endotracheal suctioning
Time frame: In the first 28 days after weaning initiation
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.
Duration of tracheostomy in situ
Time frame: Within 90 days after tracheostomy placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evert-Jan Wils, MD PhD principal investigator
Franciscus Gasthuis & Vlietland
Henrik Endeman, MD PhD study director
Erasmus Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure and Mechanical Ventilation, run by Henrik Endeman at 13 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.