Effect of Preoperative Stroke Volume Optimization Using Transthoracic Echocardiography on Arterial Hypotension Following Induction of Intravenous Anesthesia. A Prospective, Double Blinded Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- arterial hypotension
研究概览
简要总结
Immediately following the induction of general anesthesia, arterial hypotension may occur with an incidence of about 40% in patients classified as ASA 3 or 4. Perioperative arterial hypotension is associated with increased perioperative morbidity and mortality. The increased mortality associated with perioperative arterial hypotension has been reported up to 30 and 90 days after surgery. This association appears to be both dose-dependent and time-dependent (severity and duration of arterial hypotension).
EchOptimal study aims to determine whether non invasive preoperative stroke volume optimization using transthoracic echocardiography (TTE) can reduce the incidence and severity arterial hypotension following induction of general anesthesia.
This is prospective, randomized, controlled, double blinded study approved by ethics comittee.
The primary objective of this study is to compare the incidence of arterial hypotension (mean arterial pressure < 65 mmHg) within the first 15 minutes following the induction of general anesthesia, between 2 groups :
- standard current care (stroke volume optimized after induction of general anesthesia using oesophageal doppler) and
- preopertaive stroke volume optimization using transthoracic echocardiography measument of subaortic velocity time integral.
详细描述
The pre-inclusion visit consists of a preoperative evaluation of the patient in the emergency operating room. This evaluation is conducted by an anesthesiologist for all patients requiring surgical care in the emergency operating room.
This evaluation is structured similarly to a pre-anesthetic consultation conducted by an anesthesiologist for scheduled surgery. During this preoperative evaluation, the patient's medical and surgical history, current treatments, and possible allergies are collected. A targeted clinical examination is also performed.
After this evaluation, the anesthesiologist analyzes the risks posed by the patient and the specific risks associated with surgery and anesthesia to define the best perioperative strategy.
Surgical interventions are classified into three categories of postoperative cardiovascular risk (low, intermediate, or high) for cardiovascular complications within 30 days post-surgery, according to the table provided by French and European recommendations.
During this consultation, patients eligible for the study (ASA classification 3 or 4, requiring general anesthesia for intermediate or high-risk surgery) will be identified.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
statistician
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years or older,
- •Affiliated with social security,
- •Informed about the study and having signed the informed consent form,
- •Requires surgical intervention under general anesthesia,
- •Intermediate or high risk of cardiovascular events within 30 days,
- •ASA phyiscal status Classification 3 or 4
排除标准
- •Pregnant or breastfeeding women,
- •Patients under guardianship, curatorship, judicial protection, or legal protection,
- •Patients with contraindications to intravenous induction with Propofol and Remifentanil,
- •Patients not fasting at the time of surgery,
- •Patients with an immediate life-threatening emergency or requiring surgery without delay to ensure survival,
- •Patients with contraindications for placing an arterial pressure catheter in the radial artery: bilateral negative Allen's test indicating absence of ulnar collateral circulation, Raynaud's syndrome, Buerger's disease, severe dyslipidemias,
- •Patients with characteristics making the measurement of ITVSAo uninterpretable: atrial fibrillation, non-sinus electrocardiogram, severe valvulopathy, documented right or left heart failure,
- •Patients under general anesthesia before arrival in the operating room,
- •Patients receiving aminergic support before anesthetic induction,
- •Patients requiring rapid sequence induction,
- •Patients treated with ACE inhibitors/ARBs who have not discontinued the treatment on the day of the procedure
结局指标
主要结局
arterial hypotension
时间窗: From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia
Incidence (%) of arterial hypotension (mean arterial pressure \< 65 mmHg) within 15 minutes following induction of general anesthesia. Blood pressure will be continuously measured using a radial arterial pressure catheter placed before induction of anesthesia in all patients.
次要结局
- technical failure of preoperative stroke volume optimization(From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia)
- duration of arterial hypotension(From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia)
- lowest mean arterial hypotension(From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia)
- vasoactive drugs administration(From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia)
- cristalloids volume(From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia)