Point-of-care Ultrasound in the Diagnostic Work-up of Suspected Pulmonary Embolism - a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- Proportion of patients referred to CTPA or VQ after multiorgan PoCUS
研究概览
简要总结
Pulmonary embolism (PE) is a common cardiovascular condition with an estimated incidence of 0.60 to 1.12 per 1000 inhabitants in the United States of America, and the diagnosis is challenging as patients with PE present with a wide array of symptoms.
Computed tomography pulmonary angriography (CTPA) and lung ventilation-perfusion scintigraphy (VQ) are considered the gold-standards in PE-diagnostics but may not always be feasible. CTPA is contraindicated by contrast allergy or renal failure and both modalities require involvement of multiple staff-members and transport of the patient. Lung scintigraphy cannot be performed in an emergency situation, with unstable patients and patients unable to comply to the examination.
Ultrasound represent a possible tool in confirming or dismissing clinical PE suspicion. Ultrasound is non-invasive and can be performed bedside by the clinician, an approach known as point-of-care ultrasound (PoCUS), reducing both time, radiation-exposure and costs.
The aim of this study is to investigate whether integrating cardiac, lung and deep venous ultrasound in the clinical evaluation of suspected PE reduces the need for referral to CTPA or lung scintigraphy, during emergency department work up, while maintaining safety standards.
详细描述
All ultrasound examinations will be performed by a physician certified in ultrasound by the Danish Society for Emergency Physicians in accordance with the Danish Health Agency.
Based on ultrasonographic findings, PE suspicion is allocated to one of three categories:
-
Clinical suspicion of PE confirmed if ≥1 of the following ultrasound findings:
-
Visible proximal deep venous thrombus
-
≥2 hypoechoic subpleural lung consolidations with a diameter of ≥0,5cm
-
Visible right ventricular thrombus
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McConnell's sign if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
-
D-sign present in both systole and diastole if no known pulmonary hypertension, interstitial lung disease, COPD or pulmonary valve disease
If PE is confirmed by ultrasound, the physician will apply the simplified pulmonary embolism severity index score (sPESI) and estimate risk of mortality within 30 days based on clinical signs and symptoms, cardiac troponin level and RV dysfunction. Patients with intermediate-high or high risk, requiring admission to a cardiology department will be referred for CTPA. Patients with low or intermediate-low risk, not requiring admission, will be discharged with anticoagulative treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Referred or Admitted to an emergency department
- •Clinical suspicion of PE raised by physician requiring further diagnostic imaging (Well's score 0-6 with elevated age-adjusted D-dimer or Wells score >6 regardless of D-dimer)
排除标准
- •Refusal of informed consent
- •Pregnancy
- •Permanent mental disability
- •Age <18 years
- •Diagnosis of PE within the last 6 months
- •Hemodynamic instability (systolic blood pressure <90 mmHg for at least two consecutive measurements)
- •Ultrasound of heart, lungs or deep veins performed prior to enrollment
结局指标
主要结局
Proportion of patients referred to CTPA or VQ after multiorgan PoCUS
时间窗: Up to 24 hours
次要结局
- Proportion of included patients diagnosed with PE in the control and intervention group(Up to 24 hours)
- Total costs related to diagnostic work up and hospital stay as assessed by HEAT 4.2(Up to 1 year)
- Number of hours until initiation of relevant treatment after clinical evaluation in the control and intervention group.(Up to 24 hours)
- Proportion of patients in the intervention and control group discharged to their own home following clinical evaluation(Up to 24 hours)
- Proportion of patients in the reference and control group admitted to a cardiology department for telemetry monitoring (i.e. high risk PE) following clinical evaluation.(Up to 24 hours)
- Proportion of patients in the reference and control group referred to supplementary CTPA or lung scintigraphy within 30 days after inclusion(30 days)
- Number of adverse events in the intervention and control group after inclusion, including readmission, serious bleeding or death(3 months)
- Proportion of patients diagnosed with alternative diagnosis following clinical evaluation in the intervention and control group(Up to 24 hours)
- Number of subsequent cancer diagnosis in the intervention and control group within 3 months of inclusion(3 months)
- Proportion of patients in the reference and control group admitted to an intensive care unit following clinical evaluation(Up to 24 hours)
研究者
Casper Falster
Principal investigator
Odense University Hospital