Transesophageal Echocardiology Measured Left Ventricular End Diastolic Area as Guide for Administering Goal Directed Fluids During Major Oncosurgeries
Condition: Goal Directed Fluid Therapy
Study type: Interventional

Summary: 
      Intraoperative fluid management is pivotal to successful outcome of major oncosurgeries .
      Adequate volume replacement to achieve optimal cardiac performance is critical to prevent any
      deleterious consequences of under resuscitation or fluid overload . Traditionally CVP
      monitoring has been tool to guide intraoperative fluid therapy and has poor reliability as
      indicator of volume status . Transesophageal Echocardiography measured LVEDA is more reliable
      and sensitive measure of left ventricular volume to guide intraoperative fluid therapy .
      Investigators plan the study comparing total fluid requirement and postoperative outcomes in
      two groups of patients receiving central venous pressure (CVP) guided and Left ventricular
      end diastolic area( LVEDA) guided fluids for major oncosurgeries.
    

Detailed description: 
      Adult patients undergoing major oncosurgeries will be included in the study ,with Alpha
      Error(%) = 5 ,Power(%)= 80 ,required sample size per group is 29.Investigators will include
      30 patients in each group. Patients will be randomly allotted to Central Venous Pressure CVP
      Group (Control Group) or Transesophageal Echocardiography TEE Group (Study Group) according
      to computer generated randomization. In the OR 5 lead Electrocardiogram ( ECG ), Oxygen
      saturation (SPO2 ), Noninvasive blood Pressure (NIBP) , End tidal carbon di oxide (ETCO2
      )monitors will be attached .Under local anesthesia 16Gauge peripheral intravenous and Radial
      artery cannulation will be performed . Anesthesia will be induced with Fentanyl 1mcg/kg-1,
      Morphine 0.05mg/kg-1, Propofol titrated dosage 1-2 mg/kg-1 and neuromuscular blockade with
      Atracurium 0.5mg/kg-1.Trachea will be intubated with oral cuffed endotracheal tube of
      appropriate size. Anaesthesia will be maintained with O2 / Air mixture 40:60 % Intermittent
      Positive Pressure Ventilation with Sevoflurane , intermittent boluses of Fentanyl and Train
      of Four ratio guided Atracurium . Postintubation ultrasound guided internal jugular vein will
      be cannulated with B.Braun 7French 20cm, 16 G Triple lumen central venous catheter in CVP
      Group patients . My Lab Five ESAOTE TEE 022 multiplane probe ,frequency 3 to7MHz (Providian
      Medical Equipment ,OH) will be placed in TEE Group patients.Intraoperative all patients will
      be given one-third starvation fluid in first hour of surgery , maintenance fluid 2ml/hour
      crystalloid . Goal is to maintain CVP between 10 -16 cms of water (H20) in CVP Group , values
      will be recorded every 30 minutes if CVP decreases < 10 then 200 ml colloid bolus will be
      given and increase in CVP value noted . In the TEE Group TEE probe will be inserted in the
      oesophagus (40-45 cms) adjusted to obtain mid-papillary transgastric short axis view ,the
      desired view will be freezed at end-diastole and the left ventricular cavity will be traced
      including the papillary muscles to obtain left ventricular end diastolic area in cm2 , the
      average of three readings at particular interval will be noted . Every half hourly values
      will be measured and also if systolic blood pressure < 90 mm Hg . Fluid therapy will be given
      with the aim to maintain LVEDA ≥ 10 cm2 (ranging between 10-18 cm2). For readings < 10 cm2
      colloid bolus 200 ml will be given and increase in the LVEDA will be noted.For same readings
      Left Ventricular Outflow trac ( LVOT) view will be obtained to measure aortic diameter at the
      cusps and LVOT VTI , Stroke volume ( SV) will be calculated as LVOT area { Pi (LVOT diameter
      /2 } 2 × LVOT VTI and Cardiac Outpt will be calculated as SV x Heart Rate . Increase in stoke
      volume and cardiac output with colloid boluses will be noted.Urine output will be recorded
      every 30 minutes in all the patients. Titrated noradrenaline infusion (conc 0.08mg/ml ) will
      be started if Mean Arterial Pressure (MAP) < 70 mmHg with optimal fluid administration in CVP
      and TEE group .Serum lactate levels will be measured on completion of surgery and
      postoperative at 24 and 48 hours.On completion of surgery in the study group TEE probe will
      be removed and ultrasound guided internal jugular vein cannulation will be performed with
      7French 16 G cannula for administering CVP guided fluid in the Postoperative Anaesthesia care
      unit (PACU) neuromuscular blockade will be reversed and trachea extubated . In PACU both
      groups will receive CVP guided intravenous fluids , monitoring will include heart rate ,
      Blood Pressure ,SPO2 , CVP , urine output . Note will be made of any patient requiring
      postoperative ventilator support , inotropic support ,return of bowel sounds, serum lactate
      levels and serum creatinine levels at 24 and 48 hours and length of ICU stay.
    

Intervention name(s): LVEDA cm2 guided intraoperative fluid in TEE /Study Group; CVP guided intraoperative fluid in CVP / Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): Placement of Transoesophageal echocardiography probe in TEE group to measure Left ventricular end diastolic area cm2; Ultrasound guided Internal Jugular Vein catheter placement in CVP group to measure CVP value cms H2O .
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: During surgery Control group of patients will receive CVP guided fluids Study group of patients will receive TEE measured LVEDA guided fluids
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: TEE; LVEDA; GDFT; SV; CVP