Invasive Mechanical Ventilation With Tracheostomy - an Observational Study on Patient-centered Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 13
- 主要终点
- Daily dyspnea score during weaning
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years
- •Scheduled to start weaning from iMV, as per clinical decision
排除标准
- •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
结局指标
主要结局
Daily dyspnea score during weaning
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Mortality(From inclusion until 90 days after ICU discharge)
- Health-related Quality of Life (HR-QoL)(3 months after ICU discharge)
- Post-traumatic stress Disorder (PTSD)(3 months after ICU discharge)
- Anxiety and Depression(3 months after ICU discharge)
- Endotracheal suctioning(In the first 28 days after weaning initiation)
- 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.)
- Duration of tracheostomy in situ(Within 90 days after tracheostomy placement)
研究者
Henrik Endeman
Sponsor
Erasmus Medical Center