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

Study Overview
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Brief Summary
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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 .

Detailed Description
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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 .

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

Conditions
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Extravascular Lung Water

Intervention / Treatment
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* Diagnostic Test: PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .
* Diagnostic Test: CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing major Oncosurgeries under General Anaesthesia Exclusion Criteria: Left ventricular ejection fraction (LVEF )< 40% Chronic Obstructive Pulmonary Disease (COPD) BMI >30 Lung fibrosis Previous lung surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI Guided Fluid Therapy<br>Patients will receive PVI guided fluids during surgery PVI to be maintained below 12% if PVI >12 then colloid bolus 200ml will be given. Lung Ultrasonography will be performed post-intubation as baseline and at the end of surgery before extubation in 4 Lung zones in both lungs to measure total number of B-lines. | Diagnostic Test: PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .<br>* PVI probe attached to finger in PVI Group<br>|
| Active Comparator: CVP Guided Fluid Therapy<br>Patients will receive Standard CVP Guided Fluids , CVP maintained between 10-16 cms H20 , if CVP< 10 then colloid bolus 200ml will be given. Lung Ultrasonography will be performed post-intubation as baseline and at the end of surgery before extubation in 4 zones in both lungs to measure total number of B-lines. | Diagnostic Test: CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given<br>* Placement of central venous catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extravascular Lung Water detection | 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 | End of surgery upto 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of Perfusion | Serum Blood Lactate levels will be measured at end of surgery in both groups. | End of surgery upto 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Ultrasonography Extravascular Lung Water Plethysmography variability Index