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| Name | Class |
|---|---|
| Franciscus &Vlietland | OTHER |
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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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| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a tracheostomy invasively ventilated in the ICUs of one of the participating hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Evert-Jan Wils, MD PhD | Franciscus Gasthuis & Vlietland | Principal Investigator |
| Henrik Endeman, MD PhD | Erasmus Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands | ||||
| Rijnstate Ziekenhuis |
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28-day, ICU- and in-hospital mortality |
| 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. | 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. |
| Duration of tracheostomy in situ | Within 90 days after tracheostomy placement |
| Arnhem |
| Netherlands |
| Amphia Ziekenhuis | Breda | Netherlands |
| IJsselland Ziekenhuis | Capelle aan den IJssel | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Maxima Medisch Centrum | Eindhoven | Netherlands |
| St Anna ziekenhuis | Geldrop | Netherlands |
| Spaarne Gasthuis | Haarlem | Netherlands |
| Erasmus MC | Rotterdam | Netherlands |
| Franciscus Gasthuis & Vlietland | Rotterdam | Netherlands |
| Ikazia Ziekenhuis | Rotterdam | Netherlands |
| Haags Medisch Centrum Westeinde | The Hague | Netherlands |
| Elizabeth-Tweesteden Ziekenhuis | Tilburg | 3038XT | Netherlands |