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

NCT ID: NCT04659681

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-01-20

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 .

Conditions

Extravascular Lung Water

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PVI Guided Fluid Therapy

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIAGNOSTIC_TEST

PVI probe attached to finger in PVI Group

CVP Guided Fluid Therapy

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIAGNOSTIC_TEST

Placement of central venous catheter

Interventions

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

PVI probe attached to finger in PVI Group

Intervention Type: DIAGNOSTIC_TEST

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

Placement of central venous catheter

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

Sponsor Role: lead

Responsible Party

Dr Anita Kulkarni

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anita C Kulkarni, MD

Role: PRINCIPAL_INVESTIGATOR

Rajiv Gandhi Cancer Institute and Research Centre

Locations

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, , India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 27174289 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28612302 (View on PubMed)

Other Identifiers

RajivGCIRC LUS

Identifier Type: -

Identifier Source: org_study_id