Influence of Ultrasound Examination of the Lungs on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination
研究概览
简要总结
The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question[s] it aims to answer are:
- Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.
- Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.
Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 and 15 December 2024
- •signed informed consent for participation in the study
排除标准
- •reoperations on the open heart with CPB
- •surgical procedures on lungs and lung cancer in the anamnesis
- •chronic obstructive pulmonary disease, stage III
- •chronic kidney disease, stages 4 and 5
- •patients with low Risk Score profile by the Society of Thoracic Surgeons
结局指标
主要结局
The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination
时间窗: Ultrasound lung examination every second day of hospital stay; from date of admission until hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks
Participants with more than three B-lines according to ultrasound lung examination (BLUE protocol) at the day of hospital discharge
次要结局
- Cumulative dosage of diuretics(Ultrasound lung examination every second day of hospital stay; from date of admission until hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks)
- Number of nights at home after hospital discharge(Ultrasound lung examination every second day of hospital stay; from date of admission until hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks)
- Postoperative pulmonary complications(Ultrasound lung examination every second day of hospital stay; from date of admission until hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks)
研究者
Filippov Aleksei, MD, PhD
State Cardiovascular Surgeon
Saint Petersburg State University, Russia