Assessment Of Volume Responsiveness By Ultrasound Parameters Of Carotid Blood Flow In Patients With Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percent Change in Carotid Blood Flow after PLR test.
研究概览
简要总结
Resuscitation of critically ill patients has changed since the advent of goal directed therapy. Today, practitioners providing fluid resuscitation are attentive of the danger associated with volume depletion while being aware of the morbidity of volume overload. Fluid resuscitation must be rapid, precise, and individually tailored to each patient based on reliable data obtained by various means inside ICU setting.
There is no non-invasive method that can reliably and accurately identify fluid responsiveness. As such, in patients with undifferentiated shock, treatment often involves empiric fluid administration, in the hopes that volume expansion will increase preload, which will then serve to increase cardiac output (CO). However, for patients on the flat portion of the Starling curve, aggressive fluid administration results in no appreciable increase in CO and may be detrimental to hemodynamically unstable patients.
详细描述
Study location and population: Alexandria Main University Hospitals ICU, Alexandria Egypt. Approval of the Medical Ethics Committee of Alexandria Faculty of Medicine was obtained before the start of the study. Sample size was estimated using PASS version 20 program. The minimal hypothesized total sample size of 40 cardiogenic shock patients of both sexes is needed to determine the sensitivity and specificity of cardiac output measurement using either bedside ultrasound on carotid artery and TTE (Standard) while assessing volume responsiveness with 95 % confidence level and 80 % power using z-test.
Study procedures: All enrolled patients were subjected on admission to thorough history taking including age, sex, date of ICU admission and preexisting underlying disease (Diabetes Mellitus, hypertension), presence of sepsis, smoking, analgesic abuse. Full clinical examination. Severity of illness was assessed by Acute Physiological And Chronic Health Evaluation-ΙΙ (APACHE ΙΙ). ICU length of stay (LOS) and final outcome were recorded.
Noninvasive measurement of Systolic arterial pressure, diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), and temperature were recorded upon admission and after PLR.
Fluid challenge: A PLR was performed, Transferring a patient to the passive leg raising (PLR) position (in which the lower limbs are elevated at 45_ while the trunk is lying supine) transfers venous blood from the legs to the intrathoracic compartment and increases cardiac preload around 300-500 mL.
Carotid ultrasonography and Echocardiogram: Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume. Multiplying the stroke volume by the heart rate yields the cardiac output, typically reported in liters per minute.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 Y.
- •Cardiogenic shock.
排除标准
- •Age < 18 Y.
- •Pregnant females.
- •All types of shock state other than cardiogenic.
- •Peripheral arterial disease.
- •Non consenting patients.
- •Unable to tolerate passive leg raise (PLR).
- •Common carotid artery stenosis greater than 50 % (systolic peak velocity >182 cm/s and/or diastolic velocity >30 cm/s by Doppler ultrasound.
结局指标
主要结局
Percent Change in Carotid Blood Flow after PLR test.
时间窗: Change in carotid blood flow within 2 minutes after PLR.
The common carotid artery will be scanned in transverse and longitudinal planes. Spectral Doppler tracings will be then obtained by placing a 0.5 mm sample gate through the center of vessel, within 2-3 cm proximal to the carotid bulb in the longitudinal plane, in accordance to standard guidelines. The angle correction cursor will be placed parallel to the direction of blood flow. A PLR will be performed in 2 sequential steps, first step patient is seated in the semi recumbent position (45°) then using an automatic bed elevation technique, the lower limbs will be then raised to a 45° angle while the patient's trunk will be lowered in supine position. Thus, the angle between the trunk and the lower limbs will remain unchanged (135°). Percent change is \[(cardiac output after passive leg raising - carotid blood flow before passive leg raising)/carotid blood flow after passive leg raising\] × 100%. A greater than 20% increase in carotid blood flow would predict volume responsiveness.
Percent Change in Cardiac Output after PLR test.
时间窗: Change in cardiac output within 2 minutes after PLR.
Cardiac output is measured using pulsed Doppler imaging where phase-array transducer positioned just proximal to the aortic valve. The velocity time integral is measured by tracing the modal velocity then stroke volume is calculated.CO is SV multiplied by HR. A PLR will be performed in 2 sequential steps, first step patient is seated in the semi recumbent position (45°) then using an automatic bed elevation technique, the lower limbs will be then raised to a 45° angle while the patient's trunk will be lowered in supine position. Thus, the angle between the trunk and the lower limbs will remain unchanged (135°). Percent change is \[(cardiac output after passive leg raising - cardiac output before passive leg raising)/cardiac output after passive leg raising\] × 100%. A greater than 10% increase in cardiac output would predict volume responsiveness.
Blood Pressure before and after PLR test.
时间窗: Change in blood pressure 1 minute after PLR.
Measure Blood Pressure and record reading in mmHg before and after PLR test.
Heart rate before and after PLR test.
时间窗: Change in heart rate 1 minute after PLR.
Record Heart Rate readings on monitor in BPM (beat per minute) before and after PLR test.
次要结局
未报告次要终点
研究者
Nehal Yousri
Resident physician at AMUH, Principal investigator, MD student
Alexandria University