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

Recruiting

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

• Registration Number: NCT05906888
• Lead Sponsor: Henrik Endeman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-08
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily dyspnea score during weaning	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.	The severity of dyspnea during disconnection from mechanical ventilation
Daily presence of dyspnea during weaning	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.	The severity of dyspnea during disconnection from mechanical ventilation; calculated as number of days with dyspnea, and percentage of weaning days with dyspnea.

Secondary Outcome Measures

Name	Time	Method
Mortality	From inclusion until 90 days after ICU discharge	28-day, ICU- and in-hospital mortality
Weaning duration	From start weaning until separation attempt after tracheostomy placement until disconnection from the ventilator for ≥7 consecutive days, or ICU discharge, whichever comes first	The time between the first disconnection session with tracheostomy and weaning
Health-related Quality of Life (HR-QoL)	3 months after ICU discharge	The HR-QoL, as measured with the EQ-VAS (0-100). High scores indicate a high level of self-reported HR-QoL.
Post-traumatic stress Disorder (PTSD)	3 months after ICU discharge	The presence PTSD-related symptoms, as measured with the IES-6 questionnaire
Anxiety and Depression	3 months after ICU discharge	The presence of long-term symptoms of anxiety and/or depression as measured with the Hospital-related Anxiety and Depression Scale (HADS) questionnaire.
Endotracheal suctioning	In the first 28 days after weaning initiation	Number of endotracheal suctioning manoeuvres during the weaning phase
Daily discomfort score during disconnection session	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.	The severity of discomfort
Duration of tracheostomy in situ	Within 90 days after tracheostomy placement

Trial Locations

Locations (13)

IJsselland Ziekenhuis; 🇳🇱 Capelle Aan Den IJssel, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 Den Bosch, Netherlands

Haags Medisch Centrum Westeinde; 🇳🇱 Den Haag, Netherlands

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, 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, Netherlands