Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 155
- 试验地点
- 3
- 主要终点
- The time point from when the patient is considered "fit for weaning" to the actual time point for extubation
研究概览
简要总结
The purpose of this study is to determine whether the use of different sedatives affect the weaning process from mechanical ventilation in intensive care patients.
详细描述
Traditionally patients with ongoing mechanical ventilation have been sedated to assure absence of pain, anxiety and to provide comfort. Unfortunately this approach might have negative consequences such as prolonged time for mechanical ventilation, length of stay in the ICU and hospital.
In this study, the investigators would like to investigate (in an exploratory way due to the non-interventional setup) whether weaning from mechanical ventilation will be affected by the choice of sedatives - including dexmedetomidine, midazolam and propofol. This study also aims at investigating how the choice of primary sedative will affect delirium/anxiety, need of other medications (sedatives, analgesics, anti-psychotics), quality of life after ICU and the presence of Post-Traumatic Stress Disorder. In addition, the investigators aim at receiving information from the caregivers on their ICU experience, as recent data imply that not only the ICU patient but also the caregiver suffer from PTSD after the ICU stay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Admitted to a general ICU ward
- •≥ 18years
- •Intubated and mechanically ventilated for at least 24 hours
- •Need of light to moderate sedation (corresponding to RASS 0 - (-3) or MAAS 2-3)
- •Sedated with dexmedetomidine, midazolam and/or propofol
- •Good knowledge in Swedish language
- •Signed informed consent
- •Exclusion criteria:
- •Lack of fulfilling prescribed sedation regime
- •Estimated high risk of death during the study period, according to investigator (roughly equal to estimated mortality rate (EMR) > 80% )
- •Tracheotomy
- •Change in sedative drugs since the "fit for weaning" time point
- •Use of other alpha-2 agonists (clonidine) during ICU stay
- •Positive pregnancy test or currently lactating/ known pregnancy or lactation
- •Participation in other study involving use of a pharmacologically active compound
- •Patients with limitations in therapy
- •Otherwise unable to fulfill the study, according to investigator's opinion
排除标准
- 未提供
结局指标
主要结局
The time point from when the patient is considered "fit for weaning" to the actual time point for extubation
时间窗: 30 days
次要结局
- Extubation failure (re-intubation within 24 hours)(24 hours)
- Length of ICU stay (actual time of discharge)(30 days)
- Number of days using opioids(30 days)
- Number of days using antipsychotic/neuroleptic drugs(30 days)
- Anxiety/delirium assessments(30 days)
- QoL (15D)(2-4 months post-ICU discharge)
- Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire(2-4 months post-ICU discharge)
- Total duration of sedation(30 days)
- Time-point for patient being considered "fit for extubation"(30 days)
- Total time in mechanical ventilation(30 days)