Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes

Study Overview
=================
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.

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

Conditions
-----------------
Weaning Failure, Mechanical Ventilation, Patient-centered Care

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily dyspnea score during disconnection session | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of tracheostomy in situ |  | Within the first 56 days after tracheostomy placement | 
| Mortality | 28-day, 56-day, ICU- and in-hospital mortality | Within the first 56 days after tracheostomy placement | 
| 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 | 
| Weaning duration | 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. | Within the first 28 days after the first disconnection session. | 
| 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. |