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

Not Applicable

Completed

• Conditions: Extravascular Lung Water
• Interventions: 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

• Registration Number: NCT04659681
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

Brief Summary

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

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 .

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-09
• Primary Completion: 2021-01-10
• Study Completion: 2021-01-20
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI Guided Fluid Therapy	PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .	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.
CVP Guided Fluid Therapy	CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given	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.

Primary Outcome Measures

Name	Time	Method
Extravascular Lung Water detection	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

Secondary Outcome Measures

Name	Time	Method
Adequacy of Perfusion	End of surgery upto 1 hour	Serum Blood Lactate levels will be measured at end of surgery in both groups.

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 Delhi, India