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 Type
OBSERVATIONAL
Enrollment
156
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Rijnstate Ziekenhuis
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
...and 3 more locations
Daily dyspnea score during weaning
The severity of dyspnea during disconnection from mechanical ventilation
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.
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.
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.
Weaning duration
The time between the first disconnection session with tracheostomy and weaning
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
28-day, ICU- and in-hospital mortality
Time frame: 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.
Time frame: 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.
Time frame: 3 months after ICU discharge
Post-traumatic stress Disorder (PTSD)
The presence PTSD-related symptoms, as measured with the IES-6 questionnaire
Time frame: 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.
Time frame: 3 months after ICU discharge
Endotracheal suctioning
Number of endotracheal suctioning manoeuvres during the weaning phase
Time frame: In the first 28 days after weaning initiation
Daily discomfort score during disconnection session
The severity of discomfort
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
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