"Performance of a Simplified Inferior Vena Cava Collapsibility Methodology to Predict Preload Responsiveness (PR) in Spontaneously Breathing and Critically Ill Patients"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness
研究概览
简要总结
Fluid administration is a cornerstone therapy in critically ill patient. Fluid restriction or overload can therefore change patient's outcome and mortality. Close monitoring of PR (capacity of increase the cardiac output after fluid therapy) is recommended by experts' guidelines. Few bedside simple tests are available to predict PR in spontaneously breathing patients.
A team of investigators from Lille (Roger Salengro hospital) have already showed that inferior vena cava collapsibility (cVCI) accuracy of prediction of PR is excellent in standardized sponteanous breathing patient. However, the standardized inspiration maneuver remains challenging because requiring specific and non-widely available equipment.
详细描述
The primary objective of this study is to confirmed the excellent accuracy of cVCI to predict PR when standardized inspiratory maneuver is simplified.
The secondary objective is to test cVCIs in different period of cardiac cycle guided by electrocardiogram.
After receiving a loyal information patients will give their non-objection. During systematic echocardiography, patients will have to breathe in different conditions in order to homogenize their inspiratory effort. This maneuver will be repeated three times.
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
- 否
入选标准
- •Patient requiring an evaluation of PR by echocardiography for
- •Presence of at least one clinical sign of acute circulatory failure (Mean Arterial Pressure < 65 mmHg, mottling, tachycardia with Heart Rate > 90 bpm, capillary refill time > 3 sec, oliguria (urine output < 0,5 mL/kg/h over 1 hour or more))
- •Noradrenaline administration
- •Age > 18 years old
- •Spontaneous breathing patient requiring oxygen administration without mechanical assistance
排除标准
- •Intolerance of inspiratory maneuver defined by:
- •Clinical sign of acute respiratory failure
- •Active abdominal expiration
- •Hemodynamic response of passive leg raising not evaluable:
- •Intracranial hypertension
- •Impaired transthoracic or abdominal echogenicity
- •High grade aortic insufficiency
- •Pregnancy
- •Abdominal compartment syndrome
- •Lower limb amputation
- •Urgent hemodynamic therapy within half an hour
- •Modification of hemodynamic support (fluid therapy or modification of catecholamine dose)
结局指标
主要结局
Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness
时间窗: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.
the area under the ROC curve of the parameter of simplification of inspiratory effort in relation to the positive hemodynamic response positive haemodynamic response (cardiac preload-dependence) to a passive leg raising manoeuvre
次要结局
- Performance of inferior vena cava collapsibility index during a deep breath (without monitoring of inspiratory strength) to predict preload responsiveness(The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.)
- Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness during different time of cardiac cycle(The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.)