Non Invasive Ventilation After Abdominal Surgery in Postoperative Acute Respiratory Failure: a Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The primary end point for the comparison between noninvasive ventilation (NIV) and standard oxygen therapy will be the tracheal intubation within 7 days after the initiation of treatment.
研究概览
简要总结
Acute respiratory failure may occur early in the postoperative course, requiring endotracheal intubation and mechanical ventilation in selected patients, thus increasing morbidity and mortality and prolonging intensive care unit (ICU) and hospital stay.We will perform a multicenter, prospective, randomized clinical trial to compare the efficacy of non invasive ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in the treatment of postoperative acute respiratory failure. We also set out to examine the hypothesis that early application of NIV may prevent intubation and mechanical ventilation in patients who develop acute respiratory failure after abdominal surgery.
详细描述
The Non-Invasive Ventilation After Surgery (NIVAS) is an investigator-initiated, multi-center, stratified, two-arm parallel-group trial with a computer-generated allocation sequence and electronic system based randomization. The study protocol and statistical analysis plan were approved for all centers by a central Ethics Committee (France) according to French law.The NIVAS study is conducted in accordance with the declaration of Helsinki and was registered on August 2013.All centers have a long experience with NIV (more than 10 years of NIV use for ARF, and more than 5 years of NIV use for ARF following abdominal surgery). Randomization will stratified by department, age (less or more 60 years), site of surgery (upper or lower abdominal) and according to the presence or absence of postoperative epidural analgesia as this may influence outcomes. Treatment assignments will concealed from patients, research staff, the statistician, and the data monitoring and safety committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Eligibility :
- •age of more than 18 years
- •scheduled for elective or not elective abdominal surgery requiring laparotomy or laparoscopy and general anesthesia.
- •Inclusion :
- •acute respiratory failure occurring within the seven days of the surgery procedure which is defined as presence and persistence for at least 30 min and at least one of the two followings: 1) a respiratory rate of more than 30 breaths per minute and 2) clinical signs suggestive of respiratory muscle fatigue, increased work of breathing, or both, such as use of respiratory accessory muscles, paradoxical motion of the abdomen, or retraction of intercostal spaces
- •hypoxemia defined by a PaO2 lower than 60 mmHg in ambient air or lower than 80 mmHg under 15 liters O2 or an arterial O2 saturation by pulse-oximetry (SpO2) lower than 90% (PaO2/FiO2< 200 mmHg).
排除标准
- •Emergency procedure surgery (operation that must be performed as soon as possible and no longer than 12 hours after inclusion in the study)
- •previous recruitment into another trial.
- •Cardiopulmonary arrest
- •Glasgow coma scale <8
- •Absence of airway protective gag reflex
- •Upper airway obstruction
- •Pregnancy.
- •Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
- •Chronic home non invasive ventilation
结局指标
主要结局
The primary end point for the comparison between noninvasive ventilation (NIV) and standard oxygen therapy will be the tracheal intubation within 7 days after the initiation of treatment.
时间窗: primary end point will be evaluated within 7 days after the initiation of treatment.
Endotracheal intubation.
次要结局
- Gas exchange after one to two hours after inclusion in the protocol(one to two hours after inclusion in the protocol)
- nosocomial infections within the 14 days and mortality(At D-14 that means 14 days after initiation of treatment)
- length of ICU(From inclusion until the study until discharge or at 90 days maximal of ICU)