Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence of delirium episodes
研究概览
简要总结
The primary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with nicotine abstinence condition is associated with a lower incidence of delirium.
详细描述
Patients in a group with medical intervention receive nicotine patch within 24 hours after surgery. The nicotine patch is replaced every day. Delirium is evaluated every day by the Confusion Assessment Method (CAM) - ICU test. The maximum length of intervention is 7 days.
Patients in a group with placebo receive a placebo patch within 24 hours after surgery. This patch is replaced every day. Delirium is evaluated in the same way - CAM - ICU test. The maximum length of the placebo intervention is 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The participant, care provider and investigator will be masked as far as the treatment provided is concerned.
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
- •Patients undergoing a surgical procedure - urological, surgical, trauma surgery, orthopedic surgery, dental surgery)
- •Age 18 years and above
- •Patient with an assumption of nicotine abstinence (smoking a minimum 10 cigarettes/day).
- •Ex-smokers (if they stopped smoking less than 30 days prior to surgery)
- •An assumption of hospitalization at the intensive care unit (ICU) after surgery
- •Signed Informed consent
排除标准
- •Age ˂ 18 years
- •Non-signing of the informed consent
- •Patients after neurosurgical surgery, patients with traumatic brain injury, patients after a new stroke
- •Patients with psychiatric diseases
- •Nicotine, Curapor or Hydrocoll allergy
- •Patient with a heart attack, unstable angina pectoris or patients with a serious heart arrhythmia
- •Pregnant and breastfeeding patients
- •Patients with nicotine treatment
研究组 & 干预措施
Nicotine
The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days.
干预措施: Nicotine patch (Drug)
Placebo
The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days.
干预措施: Placebo patch (Other)
结局指标
主要结局
Incidence of delirium episodes
时间窗: maximum of 7 days
The number of delirium episodes, defined according to the CAM-ICU test, in the course of the seven days with the patch attached will be measured in both groups of study subjects.
次要结局
- Ventilator-hours(maximum of 7 days)
- Change in the number of days with delirium(maximum of 7 days)