Wean-Trach: Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Daily dyspnea score during disconnection session [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
Secondary Outcome Measures
- Duration of tracheostomy in situ [Within the first 56 days after tracheostomy placement]
- Mortality [Within the first 56 days after tracheostomy placement]
28-day, 56-day, ICU- and in-hospital mortality
- Health-related Quality of Life (HR-QoL) [3 months after ICU discharge]
The HR-QoL, as measured with the EQ5D-5L questionnaire. High scores indicate a high level of perceived problems.
- Health-related Quality of Life (HR-QoL) [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.
- Post-traumatic stress Disorder (PTSD) [3 months after ICU discharge]
The presence PTSD-related symptoms, as measured with the IES-6 questionnaire
- Anxiety and Depression [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.
- Endotracheal suctioning [In the first 28 days after weaning initiation]
Number of endotracheal suctioning manoeuvres during the weaning phase
- Weaning duration [Within the first 28 days after the first disconnection session.]
The time between the first disconnection session with tracheostomy and separation attempt after tracheostomy placement until disconnection from the ventilator for ≥7 consecutive days, or ICU discharge, whichever comes first.
- Daily discomfort score during disconnection session [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged ≥18 years
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Scheduled to start weaning from iMV, as per clinical decision
Exclusion Criteria:
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Deafness or Blindness
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Inability to speak or comprehend Dutch and English language
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Neuromuscular Disease
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Chronic positive pressure respiratory support at home (excluding night-time CPAP for sleep apnea)
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Support by Ventricular Assist Device or Extracorporeal life support (ECMO or ECCO2R) during tracheostomy-facilitated weaning phase.
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Tracheostomy primarily indicated for chronic upper airway obstruction or to secure airway patency due to persistent stupor/coma or swallowing disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rijnstate Ziekenhuis | Arnhem | Netherlands | ||
| 2 | Amphia Ziekenhuis | Breda | Netherlands | ||
| 3 | IJsselland Ziekenhuis | Capelle Aan Den IJssel | Netherlands | ||
| 4 | Reinier de Graaf Gasthuis | Delft | Netherlands | ||
| 5 | Jeroen Bosch Ziekenhuis | Den Bosch | Netherlands | ||
| 6 | Haags Medisch Centrum Westeinde | Den Haag | Netherlands | ||
| 7 | Catharina Ziekenhuis | Eindhoven | Netherlands | ||
| 8 | Maxima Medisch Centrum | Eindhoven | Netherlands | ||
| 9 | St Anna ziekenhuis | Geldrop | Netherlands | ||
| 10 | Spaarne Gasthuis | Haarlem | Netherlands | ||
| 11 | Erasmus MC | Rotterdam | Netherlands | ||
| 12 | Franciscus Gasthuis & Vlietland | Rotterdam | Netherlands | ||
| 13 | Ikazia Ziekenhuis | Rotterdam | Netherlands | ||
| 14 | Elizabeth-Tweesteden Ziekenhuis | Tilburg | Netherlands | 3038XT |
Sponsors and Collaborators
- Henrik Endeman
- Franciscus &Vlietland
Investigators
- Principal Investigator: Evert-Jan Wils, MD PhD, Franciscus Gasthuis & Vlietland
- Study Director: Henrik Endeman, MD PhD, Erasmus Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- W23.001