Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes (Wean-Trach)

Henrik Endeman

Status: Completed

Conditions: Weaning Failure; Patient-centered Care; Mechanical Ventilation

Study type: Observational

Funder types: Other

Identifiers

NCT05906888

W23.001

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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