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Clinical Trials/NCT04659681
NCT04659681
Completed
Not Applicable

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

Rajiv Gandhi Cancer Institute & Research Center, India1 site in 1 country120 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extravascular Lung Water
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Enrollment
120
Locations
1
Primary Endpoint
Extravascular Lung Water detection
Status
Completed
Last Updated
5 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
January 20, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Responsible Party
Principal Investigator
Principal Investigator

Dr Anita Kulkarni

Primary Investigator

Rajiv Gandhi Cancer Institute & Research Center, India

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing major Oncosurgeries under General Anaesthesia

Exclusion Criteria

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

Outcomes

Primary Outcomes

Extravascular Lung Water detection

Time Frame: 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 Outcomes

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

Study Sites (1)

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