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临床试验/NCT05969886
NCT05969886已完成不适用

Predictive Value of Ventricular-Arterial Coupling for Post-Induction Hypotension: A Prospective Observational Cohort Study

University Medical Center Ho Chi Minh City (UMC)1 个研究点 分布在 1 个国家目标入组 475 人开始时间: 2023年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
475
试验地点
1
主要终点
Prediction

研究概览

简要总结

Post-induction hypotension (PIH) is a common occurrence during the period from induction of general anesthesia to initiation of incision. PIH has been identified as an independent risk factor for postoperative major complications. Identifying high-risk patients for PIH could potentially help prevent its occurrence. Several risk factors associated with PIH have been identified, including patient conditions and use of specific anesthetic agents. Ventricular-arterial coupling (VAC) is evaluated using the ratio Ea/Ees and represents the interaction between the left ventricle (LV) and the arterial system. It reflects how changes in LV contractility (Ees) and changes in arterial load (Ea) work together to maintain optimal LV performance. A study aims to investigate the relationship between preoperative Ea/Ees ratio and the incidence of PIH (defined as MAP < 65 mmHg).

详细描述

Post-induction hypotension (PIH) is a common event due to general anesthesia in patients undergoing surgery. It is described as hypotension occurring during the period from induction of general anesthesia to initiation of incision. A universal definition of intraoperative hypotension is lacking, leading to inconsistent rates of occurrence for PIH. According to Yoshimura et al., PIH occurs in 34% of patients using the mean arterial pressure (MAP) definition of < 55 mmHg, whereas Maheshwari found PIH in 53% of patients using a MAP definition of < 65 mmHg. Furthermore, Maheshwari et al. demonstrated that PIH was an independent risk factor for postoperative major complications such as myocardial injury, cerebrovascular events, and acute kidney injury.

If high-risk patients for PIH could be identified we might potentially prevent PIH. In a systematic review, Chen et al. pointed out that the risk factors associated with PIH were ASA (American Society of Anesthesiologists) III-V, advanced age, emergency cases, hypovolaemia, long-term use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, use of propofol and high-dose of opioid. This study suggests that PIH may be the result of an interaction between the anesthetic agent and the cardiovascular condition of the patient. Conditions such as moderate-to-severe aortic regurgitation, moderate-to-severe mitral regurgitation, regional wall motion abnormalities, and echocardiography findings (e.g. elevated ratio of peak early diastolic transmitral flow velocity to annular velocity) have been identified as PIH-independent risk factors.

End-systolic elastance (Ees) is a measure of the contractile state of the left ventricle (LV). It represents the relationship between LV end-systolic pressure (LVESP) and end-systolic volume (ESV). Effective arterial elastance (Ea) is a measure of the total arterial load on the LV and is calculated as the ratio of LVESP to stroke volume (SV). Ventricular-arterial coupling (VAC), assessed by the ratio Ea/Ees, describes the interaction between the LV and arterial system. VAC reflects the interplay between the changes in LV contractility (Ees) and changes in arterial load (Ea) to maintain optimal LV performance.

Aktas et al. analyzed Ea as a predictor of PIH. The results of this study showed that pre-induction Ea had excellent predictability of hypotension. However, Ees values were not determined, thus making it speculative to conclude that pre-induction VAC is impaired in patients with high Ea. There are no studies available that assessed the role of preoperative VAC in predicting PIH. Therefore, we will investigate the relationship between the preoperative Ea/Ees ratio and the incidence of PIH (: hypotension being defined as MAP < 65 mmHg).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 18 years old.
  • Patients with ASA (American Society of Anesthesiologists) physical status 1 -
  • Elective non-cardiac, non-obstetric, and non-gynaecologic surgery
  • Preoperative transthoracic echocardiography was performed within 48 hours before surgery. The values of Ees and Ea were determined by the method of Chen.
  • Patients consented to participate in the study.
  • Patients scheduled for surgery undergoing standard general anesthesia (protocol: see below) with endotracheal intubation.
  • Patients were hemodynamically stable until the preoperative period.

排除标准

  • Uncorrected congenital heart disease, moderate-to-severe valvular disease or pulmonary hypertension, arrhythmias, anticipated difficult airway, and known allergy to anaesthetic agents.

结局指标

主要结局

Prediction

时间窗: from induction of anesthesia to incision initiation

Investigate the predictive value of the Ea/Ees ratio (along with echocardiographic variables) on PIH.

Incidence of Post-Induction Hypotension

时间窗: From induction of anesthesia to surgical incision, up to 1 hour

Post-induction hypotension (PIH) was defined according to the protocol criteria and assessed during the interval from induction of anesthesia to surgical incision. The incidence of PIH was calculated as the number of analyzed participants who developed PIH during this interval.

次要结局

  • Incidence(from induction of anesthesia to incision initiation)
  • Area Under the Receiver Operating Characteristic Curve for Prediction of Post-Induction Hypotension(From induction of anesthesia to surgical incision, up to 1 hour)
  • Fractional New Information Added for Prediction of Post-Induction Hypotension(From induction of anesthesia to surgical incision, up to 1 hour)

研究者

发起方
University Medical Center Ho Chi Minh City (UMC)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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