Clinical trial NCT04659681: Role of Lung Ultrasonography in Detecting Extravascular Lung Water in Major Oncosurgeries
Official title: Role of Lung Ultrasonography in Detecting Extravascular Lung Water in Major Oncosurgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extravascular Lung Water
Keywords: Lung Ultrasonography Extravascular Lung Water Plethysmography variability Index
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 .

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

Primary outcomes:
measure: Extravascular Lung Water detection
timeFrame: End of surgery upto 1 hour
Secondary outcomes:
measure: Adequacy of Perfusion
timeFrame: End of surgery upto 1 hour
Other outcomes:
Locations:
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
Study officials:
affiliation: Rajiv Gandhi Cancer Institute and Research Centre
name: Anita C Kulkarni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.