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临床试验/NCT04499027
NCT04499027已完成不适用

Prognostic Value of Lung Ultrasound in Predicting Intensive Care Unit Length of Stay in Adult Cardiac Surgery: A Prospective Observational Study

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2020年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
191
试验地点
1
主要终点
Intensive care Length of stay

研究概览

简要总结

Being easy, bedside, non-expensive, noninvasive and radiation free, there has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade, cardiac surgery was not an exception in both adult and pediatric surgeries Many predictors for open heart surgery outcomes have been studied in past years including The Society of Thoracic Surgeons (STS) risk score and the EuroSCORE (ES), preoperative clinical condition, associated chronic diseases, type of surgery, age, duration of cardiopulmonary bypass and brain natriuretic peptide (BNP), cystatin-C A recent study described the use of a novel postoperative lung ultrasound score scanning for B lines which denote subpleural interstitial edema in various lung regions for predicting critical care length of stay in pediatric cardiac surgeries.

The objective of the current study is to evaluate the role of the new lung ultrasound score in predicting the length of postoperative intensive care stay after adult open heart surgeries.

详细描述

After approval of the local institutional ethics committee and local institutional review board. All patients scheduled for open heart surgery in Fayoum university hospital starting from August 2020 will be enrolled in this prospective observational study until fulfilling sample size. A detailed informed consent will be signed by the eligible participants before recruitment ANESTHETIC TECHNIQUE All patients will be preoperatively assessed and investigated by complete blood count, coagulation profile, Liver and kidney functions and serum electrolytes. Chest X-ray, Electrocardiography (ECG) and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested if needed.

Patient will be premedicated by 10 mg morphine intramuscularly at morning of the operation. Prior to induction of anesthesia, standard monitoring will be applied including a five-lead electrocardiography system, a pulse oximeter probe. A peripheral intravenous (IV) cannula will be placed. An arterial will be inserted using a 20 G cannula either right or left radial artery under local anesthesia. After pre-oxygenation, general anesthesia will be induced using midazolam 2-5 mg, fentanyl (3-10 μg/kg), propofol (1-1.5 mg/Kg), followed by atracurium (0.5 mg/kg).

After trachea intubation, patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. A main stream capnogram, an esophageal temperature probe and a Foley catheter will also be placed. A triple-lumen central venous catheter will be placed usually through the right internal jugular vein.

Maintenance of anesthesia will be achieved by inhaled Isoflurane 0.4 to 1% and atracurium infusion at a rate of 0.5 mg/kg/h. After initiating extracorporeal circulation, Propofol infusion at a rate of 50-100 µg/kg/min will be added to replace isoflurane inhalation.

Patients will receive intravenous heparin (300-500 IU/kg body weight) before the initiation of cardiopulmonary bypass (CPB) to achieve an activated clotting time (ACT) of more than 480 seconds. Cardiopulmonary bypass was instituted with the use of a non-pulsatile blood flow at 2.4 L/min/m2, a non-heparin-coated circuit, and a membrane oxygenator. Mean arterial pressure will be adjusted to exceed 60mmHg before, during and after cardiopulmonary bypass (CBP) . Cardiac arrest will be induced using St Thomas crystalloid solution (Hamburg). Lactated Ringer's solution will be added to the CPB circuit to maintain reservoir volume if needed, and packed red blood cells will be infused when hemoglobin level drops to less than 7g/dl. After rewarming the patient to 37°C and weaning from CPB; Protamine sulfate will be used to reverse the effect of heparin.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients Scheduled for elective cardiac surgery for valve replacement, CABG or adult congenital (VSD or ASD) via median sternotomy

排除标准

  • subjects with inadequate acoustic windows or incomplete examinations (as defined below),
  • Patients with emergency surgeries.
  • Patients with thoracic deformities or preexisting pulmonary pathology

结局指标

主要结局

Intensive care Length of stay

时间窗: from ICU admission till patient discharge to ward assessed up to 30 days

in days

次要结局

  • in-hospital mortality(until patient discharge assessed up to 30 days)
  • Postoperative total LUS score(assessed 12 hours after the end of the operation)
  • prothrombin concentration(24 hours before operation and 1 hour after operation)
  • individual lung areas score(assessed 12 hours after the end of the operation)
  • potassium level(24 hours before operation and 1 hour after operation)
  • hemoglobin(24 hours before operation and 1 hour after operation)
  • primary pathology(24 hours before operation)
  • urea(24 hours before operation and 1 hour after operation)
  • platelet count(24 hours before operation and 1 hour after operation)
  • Arterial blood gas values(assessed up to 24 after the end of operation)
  • Intra and post-operative invasive BP(assessed up to 24 hours postoperatively)
  • creatinine(24 hours before operation and 1 hour after operation)
  • prothrombin time(24 hours before operation and 1 hour after operation)
  • EURO Score II(24 hours before operation)
  • previous associated comorbidities(24 hours before operation)
  • Cardiopulmonary Bypass (CPB) time(assessed at the end of CBP up to 12 hours from start of operation)
  • Concomitant vasoactive medications(assessed at te end of the operation up to 12 hours from the start of the operation)
  • Intra and post-operative heart rate(assessed up to 24 hours postoperatively)
  • extubation time(assessed up to 30 days)
  • planned operative procedure(24 hours before operation)
  • liver enzymes(24 hours before operation and 1 hour after operation)
  • sodium level(24 hours before operation and 1 hour after operation)
  • Post-operative complications(assessed until patient discharge or up to 30 days postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Hamed

Associate professor of Amesthesiology

Fayoum University Hospital

研究点 (1)

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