Speckle Tracking Evaluation of the Impact of Inhaled Nitric Oxide on the Right Ventricle in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Variation from baseline of systolic function after iNO administration
研究概览
简要总结
Acute cor pulmonale is one of deadly complications of mechanically ventilated acute respiratory distress syndrome (ARDS), which can lead to right ventricular dysfunction and worsen the hemodynamics of the patient. For several years, transthoracic (TTE) and transesophageal echocardiography (TEE) have replaced the pulmonary artery catheter to monitor cardiac function reliably and non-invasively.
Speckle tracking is an echocardiographic technique that allows a two-dimensional strain (2D) analysis of right ventricular systolic function. Right ventricular global strain (RVGLS) is a strain parameter, allowing an early and more accurate diagnosis of right ventricular dysfunction than conventional parameters.
This project will consist of performing TTE and TEE measurements at H0, 30min, H1, H2, and H24 after iNO administration in patient with ARDS under mechanical ventilation. The patient will be declared responder to iNO, if there is an increase of more than 20% of the PaO2/FiO2. 30 minutes after a dose of 10ppm of iNO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Adult patient (age > 18 years)
- •Hospitalized in the intensive care and post-operative care unit of the Amiens-Picardie University Hospital
- •Patient with ARDS (defined by the Berlin criteria) requiring mechanical ventilation with a P/F ratio < 200 and requiring iNO
- •Beneficiary of social security
- •Signature of the consent to participate in the study by the patient or, if unconscious, his legal representative/next of kin
排除标准
- •Pregnant or breastfeeding woman
- •Contraindications to TEE (major upper gastro-intestinal surgery, mediastinal radiotherapy, active esophagitis, esophageal varices)
- •Contraindications to the placement of an esophageal probe (recent upper gastro-intestinal surgery, active ulcer, active esophagitis)
- •Presence of atrial fibrillation on echocardiographic examinations
- •Contraindications to the administration of iNO
- •Patients with chronic treatment allowing pulmonary arterial vasodilatation by sildenafil.
结局指标
主要结局
Variation from baseline of systolic function after iNO administration
时间窗: 30 minutes
Systolic function will be assessed with "in speckle tracking RV" in the presence or not of a response to iNO 30 minutes after its administration, Systolic function will be assessed with "in speckle tracking RV" in patients with moderate to severe ARDS under mechanical ventilation.
次要结局
- Variation from baseline of systolic function after iNO administration(at 24 hours)
- Variation from baseline of systolic function after iNO administration(at 1 hour)
- Variation from baseline of systolic function after iNO administration(at 2 hours)