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临床试验/NCT03514706
NCT03514706已完成不适用

The Ultrasound Estimation of Extravascular Lung Water in Volume Controlled Versus Pressure Controlled Ventilation After One Lung Ventilation in Thoracoscopic Surgery. A Comparative Study

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Lung ultrasound score

研究概览

简要总结

Volume controlled ventilation (VCV) and pressure controlled ventilation (PCV) are the common ventilatory modes during OLV undergoing thoracic surgery. A controversy regarding which ventilation mode is better for oxygenation during OLV with PCV enhances oxygenation more than VCV ;given its initial high peak inspiratory flow rates and its rapidly decelerating flow pattern. However, this high peak inspiratory flow rate might also provoke lung injury via shearing and traction forces on the alveoli. Extravascular lung water describes water within the lungs but outside pulmonary vasculature. Lung ultrasound (LUS) assessment of EVLW by B-lines provides a reliable and easy alternative.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

盲法说明

Lung ultrasound will be done by an investigator blinded to group allocation

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged (18-60 years), undergoing elective thoracoscopic surgery with one lung ventilation

排除标准

  • Emergency surgeries.
  • Left Ventricular ejection fraction less than 40%.
  • Any patient known to have pulmonary hypertension
  • Patients with preoperative congestive heart failure, cardiogenic shock, preoperative pulmonary edema
  • Hepatic patients (liver functions double the upper reference range)
  • Morbid obesity (BMI > 40).
  • Renally impaired patients with creatinine more than 2 mg/dl.
  • Any patient with respiratory dysfunction (FEV1<60% of the expected).
  • Any patient with previous thoracic surgery.
  • One lung ventilation more than 2 hours

研究组 & 干预措施

Volume controlled ventilation

Experimental

Group V: Patients will receive volume controlled mechanical ventilation. (Vt 7ml/kg ideal body weight).

干预措施: volume controlled ventilation (Diagnostic Test)

Pressure controlled ventilation

Experimental

Group P: Patients will receive pressure controlled mechanical ventilation. (to achieve Vt 7 ml/kg ideal body weight, Pmax 30 cmH2O)

干预措施: pressure controlled ventilation (Diagnostic Test)

结局指标

主要结局

Lung ultrasound score

时间窗: change of lung ultrasound scores introperatively during double lung and single lung ventilation and after 2 hours postoperatively compared to baseline scores before anesthesia induction

The sum of B lines reflects the extent of lung water accumulation. The lung ultrasound score(LUS) will be obtained by scanning 12-rib interspaces. The dependent lung will be divided into six areas: two anterior areas, two lateral areas, and two posterior areas. The anterior chest wall (zone 1) will be delineated from the parasternal to the anterior axillary line and will be divided into upper and lower halves, from the clavicle to the third intercostal space and from the third to the diaphragm. The lateral area (zone 2) will be delineated from the anterior to the posterior axillary line and was divided into upper and basal halves. The posterior area (zone 3) will be considered as the zone beyond the posterior axillary line. The sum of B-lines on each scanning site (0: absence; 1: B7 lines: multiple B-lines 7 mm apart; 2: B3 lines: multiple B 3 mm apart; 3: consolidation) yields a score from 0 to 36(10) score for the ventilated lung is only from 0-18.

次要结局

未报告次要终点

研究者

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

Hisham Hosny

Associate professor

Cairo University

研究点 (2)

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