Clinical trial NCT05906888: Weaning with Tracheostomy - an Observational Study on Patient-centered Outcomes
Official title: Invasive Mechanical Ventilation with Tracheostomy - an Observational Study on Patient-centered Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Weaning Failure
Mechanical Ventilation
Patient-centered Care
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Franciscus &Vlietland
First posted: 2023-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a tracheostomy invasively ventilated in the ICUs of one of the participating hospitals.

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.


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

Primary outcomes:
measure: Daily dyspnea score during weaning
timeFrame: 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.
measure: Daily presence of dyspnea during weaning
timeFrame: 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:
measure: Weaning duration
timeFrame: From start weaning until separation attempt after tracheostomy placement until disconnection from the ventilator for ≥7 consecutive days, or ICU discharge, whichever comes first
measure: Mortality
timeFrame: From inclusion until 90 days after ICU discharge
measure: Health-related Quality of Life (HR-QoL)
timeFrame: 3 months after ICU discharge
measure: Health-related Quality of Life (HR-QoL)
timeFrame: 3 months after ICU discharge
measure: Post-traumatic stress Disorder (PTSD)
timeFrame: 3 months after ICU discharge
measure: Anxiety and Depression
timeFrame: 3 months after ICU discharge
measure: Endotracheal suctioning
timeFrame: In the first 28 days after weaning initiation
measure: Daily discomfort score during disconnection session
timeFrame: 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.
measure: Duration of tracheostomy in situ
timeFrame: Within 90 days after tracheostomy placement
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Capelle Aan Den IJssel
country: Netherlands
facility: IJsselland Ziekenhuis
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haags Medisch Centrum Westeinde
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Geldrop
country: Netherlands
facility: St Anna ziekenhuis
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Tilburg
country: Netherlands
facility: Elizabeth-Tweesteden Ziekenhuis
Study officials:
affiliation: Franciscus Gasthuis & Vlietland
name: Evert-Jan Wils, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Henrik Endeman, MD PhD
role: STUDY_DIRECTOR
References: