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临床试验/NCT04659681
NCT04659681已完成不适用

Role of Lung Ultrasonography in Detecting Extravascular Lung Water in Major Oncosurgeries

Rajiv Gandhi Cancer Institute & Research Center, India2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Extravascular Lung Water detection

研究概览

简要总结

During major surgeries optimal intravenous fluid administration is essential , conventional method may cause fluid overload , increased extravascular Lung water can lead to postoperative cardio-respiratory complications , this study was designed to detect immediate postoperative EVLW with Lung Ultrasonography in patients receiving Central venous pressure Guided and Pleth variability Index (PVI) guided fluids intraoperatively .

详细描述

Standard General Anaesthesia with Endotracheal Tube and Intermittent Positive Pressure Ventilation (IPPV) was given to all patients,Monitoring included 5 lead ECG, Oxygen Saturation (SPO2), End tidal Carbon di oxide (ETCO2), Invasive Blood Pressure (IBP) , Central venous Pressure (CVP), Pleth variability Index (PVI) in study group and Bispectral Index (BIS) , Core temperature .Postintubation before commencement of surgery baseline Lung Ultrasonography will be performed with non-linear probe in 4 zones on Right and Left Lung-- Zone I Right Midclavicular in second intercostal space , Zone II Right Parasternal in third intercostal space, Zone III Anterior axillary line in fourth intercostal space Zone IV Posterior axillary line in the V intercostal space. Zone V to VIII in Corresponding spaces on the Left side . In the control Group CVP Guided IV fluids were given during surgery CVP will be maintained between 10-16 cms H20 , for CVP values < 10 cms H20 colloid bolus 200ml was given.In the Study Group PVI guided IV Fluids will be given to maintain PVI <12 for increase in PVI value > 12 Colloid bolus 200 ml will be given. After the completion of surgery and before extubation Lung Ultrasonography will be performed in all 8 Zones in both lungs to identify B Lines and total number of B lines will be calculated , Extra Vascular Lung Water (EVLW) Grading will be done as B Lines <5 Mild, between 5-15 moderate , > 15 severe .Total IV Fluids along with colloid boluses will be calculated , Postintubation as Baseline and after the completion of surgery Arterial blood gas analysis will be done for Alveolar-Arterial Oxygenation Pa02 (A-a) and blood Lactate values . After completion of surgery neuromuscular blockade will be reversed and trachea extubated .

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
Single (Participant)

盲法说明

Participant was masked about Group it belonged

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

  • Patients undergoing major Oncosurgeries under General Anaesthesia

排除标准

  • Left ventricular ejection fraction (LVEF )< 40%
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Lung fibrosis
  • Previous lung surgery

结局指标

主要结局

Extravascular Lung Water detection

时间窗: End of surgery upto 1 hour

At the end of surgery before extubation Lung Ultrasonography will be performed in 4 Zones bilaterally to detect total number of B lines in both groups

次要结局

  • Adequacy of Perfusion(End of surgery upto 1 hour)

研究者

发起方
Rajiv Gandhi Cancer Institute & Research Center, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anita Kulkarni

Primary Investigator

Rajiv Gandhi Cancer Institute & Research Center, India

研究点 (2)

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