Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial (Pre-IcarUS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Inter-observer disagreement at admission lung ultrasound
研究概览
简要总结
In Switzerland 15% of discharged patients are readmitted within 30 days. Acute heart failure is the leading cause of hospital admission and one of the most frequent reasons for re-admission, mainly because of congestion-driven symptoms. Residual congestion is noted in 10%-15% of patients at discharge and is associated with an increased risk of re-admission and mortality. Lung ultrasound outperforms both chest X-ray and physical examination in detection of lung congestion. Several semiquantitative scanning protocols exist for quantifying congestion. The aim of this study is to compare for the first time two widely used lung ultrasound protocols, one exhaustive (28-points) and one simplified (8-points), in real-time settings. The focus is placed on reproducibility (expert-beginner interobserver concordance), feasibility (time consumption for images acquisition and interpretation) and performance (detection of B-lines clearing) of both scores. Semi-quantitative method is expected to have better feasibility with similar reproducibility and performance.
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
- •Diagnosis of acute heart failure on admission chart (primary or secondary diagnosis)
- •Admission from the emergency room to a general internal medicine ward
- •Presentation of acute heart failure according to European Society of Cardiology :
- •Presence of ≥1 symptom or sign based on admission chart review and
- •Raised value of N terminal-pro-brain natriuretic peptide (>300 ng/l)
排除标准
- •Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion, previous lung surgery
- •Inability or unwillingness to give consent
- •Presence of oligo-anuric end stage renal disease
结局指标
主要结局
Inter-observer disagreement at admission lung ultrasound
时间窗: Day 0
The primary endpoint is the amount of disagreement between beginner and expert echographers at admission lung ultrasound. In order to compare protocols using different grading systems, a common 4-levels interstitial syndrome (IS) severity scale is defined. For the 28-point protocol, rating of total number of B-lines will be classified according to literature in severe (\>30), moderate (16-30), mild (6-15) or no signs of IS (≤5 B-lines). For the 8-point protocol, IS is arbitrarily classified as follows: 'severe' (6-8), 'moderate' (4-5), mild (2-3) and 'no signs' (0-1 positive zones).
Inter-observer disagreement at follow-up lung ultrasound
时间窗: Day 4 to 6
The amount of disagreement between beginner and expert echographers is measured at follow-up lung ultrasound. In order to compare protocols using different grading systems, a common 4-levels IS severity scale is defined. For the 28-point protocol, rating of total number of B-lines will be classified according to literature in severe (\>30), moderate (16-30), mild (6-15) or no signs of IS (≤5 B-lines). For the 8-point protocol, IS is arbitrarily classified as follows: 'severe' (6-8), 'moderate' (4-5), mild (2-3) and 'no signs' (0-1 positive zones).
次要结局
- Time consumption for images acquisition and interpretation at follow-up lung ultrasound(Day 4 to 6)
- Post-discharge readmission and mortality at 180 days(Day 180 post-discharge)
- Time consumption for images acquisition and interpretation at admission lung ultrasound(Day 0)
- Change in interstitial syndrome severity scale and amount of B-lines at follow-up ultrasound from baseline(Day 0, Day 4 to 6)
- Post-discharge readmission and mortality at 30 days(Day 30 post-discharge)
- Post-discharge readmission and mortality at 60 days(Day 60 post-discharge)
- Post-discharge readmission and mortality at 90 days(Day 90 post-discharge)
研究者
Antonio Leidi
Principal Investigator
University Hospital, Geneva