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

Extravascular Lung Water Clinical Trial

— LUS EVLW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659681
• Other study ID #: RajivGCIRC LUS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: April 2021
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 20, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Extravascular Lung Water

Intervention

Diagnostic Test:
• PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .
PVI probe attached to finger in PVI Group
• CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given
Placement of central venous catheter

Locations

Country	Name	City	State
India	Rajiv Gandhi Cancer Institute and Research Centre	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

References & Publications (2)

Anile A, Russo J, Castiglione G, Volpicelli G. A simplified lung ultrasound approach to detect increased extravascular lung water in critically ill patients. Crit Ultrasound J. 2017 Dec;9(1):13. doi: 10.1186/s13089-017-0068-x. Epub 2017 Jun 13. — View Citation

Picano E, Pellikka PA. Ultrasound of extravascular lung water: a new standard for pulmonary congestion. Eur Heart J. 2016 Jul 14;37(27):2097-104. doi: 10.1093/eurheartj/ehw164. Epub 2016 May 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adequacy of Perfusion	Serum Blood Lactate levels will be measured at end of surgery in both groups.	End of surgery upto 1 hour