The Effect of More Frequent Noninvasive Blood Pressure Measurement on the Detection of Intraoperative Hypotension
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute
研究概览
简要总结
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition.
The aim of the study is determined as the relationship between two different time intervals of measurements and time spent hypotensive under harm thresholds in non-cardiac surgery in adults having non-cardiac surgery. Secondarily, it will be determined if more frequent non-invasive blood pressure measurement use decreases postoperative acute kidney injury. Exploratory, it will be evaluated if more frequent non-invasive blood pressure use causes pain or nerve injury in the arms or not.
详细描述
Around 300 million surgical operations are performed globally, and of these, 40 to 50 million are performed in the USA. The perioperative period is characterized by hemodynamic instability and, most importantly, hypotension. Intraoperative hypotension is frequent, and the incidence ranges between 5% and 99% during non-cardiac surgery, depending on the definition.
Intraoperative hypotension can cause an ischemia-reperfusion injury, manifesting as dysfunction of any vital organ. The kidneys and the heart are the most sensitive organs to be affected. Numerous analyses in diverse non-cardiac surgical populations demonstrate clinically meaningful associations between intraoperative hypotension and myocardial injury, acute kidney injury, serious composite complications, and death. The association between hypotension and various complications seems clear. However, hypotension exposure time provokes acute kidney remains unclear.
Myocardial injury after non-cardiac surgery manifests as an acute increase in the concentration of cardiac biomarkers and occurs in 11.6% of non-cardiac surgeries. Myocardial injury after non-cardiac surgery is also associated with a hypotension period, even with only small biomarker increases. Ischemia-reperfusion injury due to hypotension may substantially contribute to postoperative myocardial injury.
Acute kidney injury (AKI) is defined as creatinine increase and urine output and is well-validated in medical patients. Acute kidney injury reportedly prolongs hospitalization and increases readmissions; it is also associated with increased healthcare costs, sepsis, and mortality. However, most of the data regarding outcomes of acute kidney injury originate from cohorts of hospitalized medical patients, patients admitted to critical care units, or trauma victims. Postoperative kidney injury can increase after surgery because of dehydration or surgical muscle injury. Furthermore, a recent study found a strong relationship between intraoperative hypotension exposure and non-cardiac surgery-related acute kidney injury in patients <60 years of age. However, another study found no independent association between varying ages and postoperative acute kidney injury without evaluating intraoperative hypotension exposure.
The definition of intraoperative hypotension is that a mean arterial pressure (MAP) of 65 mm Hg is accepted as a threshold predicting myocardial injury, which is a leading cause of 30-day postoperative mortality. Additionally, the risk of end-organ dysfunction increases with the length of low arterial blood pressure. According to Walsh et al., as little as 1 minute of exposure to MAP <55 mm Hg is associated with myocardial injury, any cardiac complication, and kidney injury after non-cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years;
- •ASA Physical Status 1 and 3;
- •Non-cardiac surgery with expected surgery duration ≥ 2 hours;
- •Supine position during the surgery;
- •Regional or general anesthesia;
- •Planned hospital stay time of at least 24 hours.
排除标准
- •Patients who confirm to be pregnant and/or nursing mothers;
- •Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
- •Has a condition that precludes routine or tight blood pressure management;
- •Mean arterial blood pressure differences between right and left arm ≥ 5 mmHg;
- •Patient who has physically disabled their arms:
- •5. Emergency surgery.
结局指标
主要结局
The time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute
时间窗: Every 2.5 minute in the surgery upto end of the surgery.
For the primary outcome, clinically important difference will be the time-average spend hypotensive (under MAP thresholds of 65 mmHg) for at least 1 minute since it has been shown clinically important in previous studies . We will assess this primary outcome in adults having non-cardiac surgery, a 2.5-minute interval of intraoperative blood measurement group compared to the standard 5-minute interval group.
次要结局
- the time-average spend hypotensive (under MAP thresholds of <60, <50, and <40 mmHg [mmHg]) for at least 1 minute.(Every 2.5 minute in the surgery upto end of the surgery.)
研究者
Yasin Tire, MD
Assoc. Prof. Dr. Yasin Tire
Konya City Hospital