Role of Lung Ultrasonography in Detecting Extravascular Lung Water in Major Oncosurgeries (LUS EVLW)

Rajiv Gandhi Cancer Institute & Research Center, India

Status: Completed

Conditions: Extravascular Lung Water

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04659681

RajivGCIRC LUS

Details and patient eligibility

About

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 .

Full description

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 .

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

PVI Guided Fluid Therapy

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .

CVP Guided Fluid Therapy

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given