Transthoracic Echocardiography of Inferior Vena Cava Before Spinal Anesthesia Can Predict Hypotension in Elderly Orthopaedic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Preoperative performance of the dIVCmax/IVCCI ratio
研究概览
简要总结
Study Protocol: Outcome Measurements Primary Outcome The main outcome will be the preoperative performance of the dIVCmax/IVCCI ratio to foresee the incidence of hypotension after spinal anesthesia in a greater extent to that of the established IVCCI measurements.
Secondary Outcomes To identify other echocardiographic or clinical measurements that can predict an intraoperative spinal-induced haemodynamic instability.
Sample Size Calculation A pilot study of 20 patients revealed a detected area under the ROC curve (AUC) of 0,91 for dIVCmax/IVCCI and for dIVCmax 0,82 with rank correlation between the two assays being 0.87 in both positive and negative cases. Based on this result, a sample of 56 patients will achieve 80% power to detect significant difference (at a level 0.05) between dIVCmax/IVCCI and dIVCmax.
Potential Benefits of the Study The results of this study will allow us to determine which clinical or US-measurement can yield better performance so as a preoperative prediction of spinal-induced hypotension can be achieved; that way these measurements can permit and guide a targeted preoperative fluid challenges prior to the implementation of spinal anesthesia Potential Side Effects of the Study Participation in this protocol will not put patients at higher risk for complications since we do not perform any intervention (either pharmacological or surgical) There will be no occupational risks to researchers or assistants. Proposed Timetable According to the exclusion criteria and taking into account the number of cases performed in our department per monthly basis, it should take us approximately 6 months to recruit 60 patients.
详细描述
AIM OF THE STUDY
We hypothesized, therefore, that the preoperative dIVCmax/IVCCI ratio (maximum diameter of inferior vena cava-IVC- at the expiration = dIVCmax and the collapsibility index of the IVC =IVCCI) could greater foresee the incidence of hypotension after spinal anesthesia than the established IVCCI measurements. In light of this hypothesis, we prospectively examined both the dIVCmax/IVCCI ratio and IVCCI before spinal anesthesia in a population who fulfilled predetermined inclusion criteria and we set out to evaluate the diagnostic performance of this indices in predicting spinal-induced hypotension.
METHODOLOGY In the present observational prospective study, consecutive sampling is used to recruit ageing patients (>70 years) who sustained orthopaedic operation under spinal anesthesia.
According to our department policy, the documentation of a cardiac disease in our patients takes place during the routine preoperative anesthetic evaluation always with the cooperation of consultant cardiologists. Patients' medical history, physical examination, ECG, and X-ray assessment are standard practice supplemented by specific exams or tests Echocardiogrphic protocol and measurements A TTE is performed in all patients before spinal anaesthesia (Vivid T8, GE Healthcare, Waukesha, Wisconsin, USA) equipped with a 2-5 MHz phased array transducer. All echocardiograms is carried out by the same anesthesiologist/intensivist (TS), who has 12 years of experience in perioperative echocardiography. All data are saved and stored digitally for off-line analysis.
A standard intraoperative TTE protocol is being used in all patients. and included the following views: subxiphoid4-chamber (SUBX), apical 4-chamber (4CH), apical 2-chamber (2CH), apical 3-chamber (3CH), parasternal long (LAX) and short axis (SAX) windows.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with AHA/ACC stage I, II or III with their cardiac disease status in compensated status -
排除标准
- •patients with AHA/ACC stage IV
结局指标
主要结局
Preoperative performance of the dIVCmax/IVCCI ratio
时间窗: 6 months
The main outcome will be the preoperative performance of the dIVCmax/IVCCI ratio to foresee the incidence of hypotension after spinal anesthesia in a greater extent to that of the established IVCCI measurements
次要结局
- Echocardiographic or clinical measurements(6 months)
研究者
Theodosis Saranteas, MD
Assistant Professor
National and Kapodistrian University of Athens
