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

Mechanical Ventilation Clinical Trial

— Wean-Trach  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906888
• Other study ID #: W23.001
• Status: Recruiting
• Start date: May 8, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Erasmus Medical Center
• Contact: Matthijs Janssen
• Phone: +31107035142
• Email: m.l.janssen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Patient-centered Care
• Weaning Failure

Locations

Country	Name	City	State
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	IJsselland Ziekenhuis	Capelle Aan Den IJssel
Netherlands	Reinier de Graaf Gasthuis	Delft
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	Haags Medisch Centrum Westeinde	Den Haag
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	Elizabeth-Tweesteden Ziekenhuis	Tilburg

Sponsors (2)

Lead Sponsor	Collaborator
Henrik Endeman	Franciscus &Vlietland

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of tracheostomy in situ		Within the first 56 days after tracheostomy placement
Secondary	Mortality	28-day, 56-day, ICU- and in-hospital mortality	Within the first 56 days after tracheostomy placement
Secondary	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
Secondary	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
Secondary	Post-traumatic stress Disorder (PTSD)	The presence PTSD-related symptoms, as measured with the IES-6 questionnaire	3 months after ICU discharge
Secondary	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
Secondary	Endotracheal suctioning	Number of endotracheal suctioning manoeuvres during the weaning phase	In the first 28 days after weaning initiation
Secondary	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.
Secondary	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.