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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05906888
Other study ID # W23.001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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