Multicenter, Randomized, Open Study, Assessing Prophylactic Noninvasive Ventilation in Intensive Care Unit vs Postoperative Standard Care for Patients With High Risk of Postoperative Pulmonary Complication With Preoperative ARISCAT Score
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 3
- 主要终点
- Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)
研究概览
简要总结
Postoperative pulmonary complications are one of the most common complications after surgery.
Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications.
Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest.
The difficulty for the practitioner is to target patients at higher risk of developing a postoperative pulmonary complications in order to guiding them to a post-operative specialized care pathway.
The use of the ARISCAT score, validated on a large European prospective cohort, makes it possible to evaluate, preoperatively, the risk of occurrence of postoperative pulmonary complication in the patient.
The hypothesis of the present research is that early postoperative preventive treatment with noninvasive ventilation, in patients at risk of postoperative pulmonary complications according to the preoperative evaluation according to the ARISCAT score, could have an interest in reducing these complications with a superior efficiency over standard techniques.
详细描述
After verification of eligibility criteria and ARISCAT score, patients at high risk of COPD are randomized in the study.
At the exit of the operating room, patients are referred to the services according to their randomization arm :
- arm with prophylactic noninvasive ventilation in intensive care unit. Patients will receive noninvasive ventilation for a maximum of 48 hours. Sessions last 1 hour and are repeated every 2 to 3 hours
- arm with standard care in conventional care unit. Patients receive standard care such as physiotherapy.
In both arms, patient follow-up is 7 days maximum.
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
- 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
- •Patient 18 years of age or older
- •Patient scheduled for surgery or considered semi-urgent (=pre-anesthesia consultation <48h before the surgical procedure) under General Anesthesia or under Loco-Regional Anesthesia
- •Patient with an ARISCAT score higher than or equal to 45 - Obtaining the signed written consent of the patient
- •Patient affiliated to a social security scheme
排除标准
- •Minor patients, pregnant or lactating women
- •Obstetrical interventions
- •Surgery under Local Anesthesia or Peripheral Nerve,
- •Interventions taking place outside an interventional room
- •Interventions for previous surgical complications
- •Second surgery during study
- •Organ transplantation
- •Patients already intubated in preoperative
- •Outpatient surgery
- •Refusal of participation or inability to issue informed consent
- •Person deprived of liberty or adult under guardianship
- •Participation in another interventional study
研究组 & 干预措施
postoperative standard care
Standard care after surgery in postoperative unit
干预措施: postoperative standard care (Procedure)
Prophylactic non-invasive ventilation
Prophylactic noninvasive ventilation in postoperative and intensive care unit
干预措施: Prophylactic non-invasive ventilation (Procedure)
结局指标
主要结局
Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)
时间窗: Up to 7 days post-surgery or until hospital discharge (study duration: 23 months)
The outcome was reported as the count of participants who experienced acute respiratory failure, defined as the need for invasive or non-invasive mechanical ventilation within 7 days after surgery or until hospital discharge, whichever occurred first. All events were validated by an adjudication committee in this randomized, single-blind trial.
次要结局
- Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria)(30days)
- Reintubation Rate Within 7 Days(7 days)