Multicentric Evaluation of a Daily Nicotine Patch Administration on Mechanical Ventilation Weaning in Smoking Patients Hospitalized in Intensive Care Unit
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Length of mechanical ventilation expressed in hours
研究概览
简要总结
Nicotine patches are frequently used in smoking patients during their stay in the ICU in order to avoid tobacco's weaning symptoms which are likely to interfere with mechanical ventilation weaning.
Until now the effectiveness of this treatment has not been proven. The aim of this study (NICOREA study) is to determine if a difference exists on the duration of mechanical ventilation once patients receive or not a nicotine substitute.
详细描述
Six hundred mechanically ventilated patients are going to be enrolled to receive nicotine or placebo during a 24 month period in 14 centers in France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 et 80 yrs
- •SOFA score below or equal to 16 at randomization time
- •Patient expected to be mechanically ventilated for at least 24hrs
- •Patient known to be usually smoking more than 10 cigarettes per day according to her/him or to a next of kin
- •Consent obtained from the patient or a next of kin.
排除标准
- •Patients having been in the ICU for more than 72 hours or mechanically ventilated since more than 48 hours
- •Isolated brain trauma
- •Patients weaned from tobacco since more than 21 days
- •Patients smoking only pipe, cigars or cannabis
- •Chronic skin diseases (psoriasis, dermatitis, etc)
- •Patients receiving other products containing nicotine
- •Patients not understanding French
- •Patients with severe hearing deficiency
- •Mechanical ventilation weaning using an expert system
- •Disease with short term fatal issue
- •Pregnancy
- •Patient depending on other persons for most every day actions
- •Myocardial infarction within 3 months, ventricular arrhythmia's
- •Stroke during the 3 last months
- •Known hypersensibility to nicotine or patches
研究组 & 干预措施
Nicotine
One or two 15mg nicotine patch(es) applied from 6am to 10pm according to the patients tobacco dependence measured by the Fagerström scale.
干预措施: Nicotine patch (Drug)
Placebo
One or two patch(es) with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Length of mechanical ventilation expressed in hours
时间窗: 48 hours after extubation
Measured between the time of tracheal intubation to tracheal extubation without reintubation for at least 48 hours
次要结局
- Length of stay in the ICU expressed in day(s)(Within the first 30 days)
- Number of failure of mechanical ventilation weaning(Within the first 30 days)
- Incidence of score above +1 of the RASS scale measured every 4 hours(Within the first 30 days)
- Number of days with delirium assessed by the CAM-ICU score(Within the first 30 days)
- 28th day mortality rate(betwwen 28th and 48th days)
- Number of hours under sedation below RASS -4, between -3,-2, -2,+1 indexed by the overall duration of sedation(Within the first 30 days)
- Number of self-extubation(s)(Within the first 30 days)
- Number of pneumonia acquired during mechanical ventilation(Within the first 30 days)
- SOFA score(between 48 and 72 hrs)
- Tobacco weaning rate at hospital discharge(Within the first 120 days)