Congenital Cardiac Disorders Clinical Trial
Official title:
Effect of Ultra Filtration on Extravascular Lung Water Assessed by Lung Ultrasound in Pediatric Cardiac Surgery
study will assess the effect the ultrafiltration after pediatric congenital heart surgery on
cardiopulmonary bypass. patients will be divided into two groups. first group will receive
ultrafiltration and the second group will be control group without filtration.
we will assess extravascular lung water by lung ultrasound, arterial oxygen tension and
duration of ventilation.
The anesthesiologist will interview the guardians; examine the patients, checking all routine
investigations include: CBC(complete blood count), coagulation profile, liver function tests,
renal function tests, blood grouping, chest X-ray, recent echocardiography and angiography if
available.
Children will be received Midazolam 0.3 mg/kg IM (intramuscular) and Atropine 0.02 mg/kg IM
10 min as pre-medication before induction.
Induction of anesthesia will be established using fentanyl, 1-5µg/kg, ketamine 1-2 g/kg.
Atracurium 0.5mg/kg will be administered to facilitate endotracheal intubation and repeated
intraoperative as required to maintain muscle relaxation. Anesthesia will be maintained using
sevoflurane 0.3%-2 % in oxygen-air mixture (1:1 ratio). A central venous line will be
inserted and arterial line for invasive blood pressure monitoring. The use of inotropes will
be guided by the patient's hemodynamics after surgical repair. Dobutamine 5-10 µg/Kg/min,
Tridil 1-4 µg/Kg/ min, Adrenaline 0.05µg/kg/min or Milrinone 0.5µg/kg/min will be used
according to pathophysiology and Intraoperative state of patient.
In all patients, a median sternotomy will be performed. CPB will be initiated after full
heparinization in a dose of 300-400 I.U to achieve a n ACT( activated clotting time) of 450
sec or 3 times baseline reading followed by the standard aorta-bicaval cannulation. A
membrane oxygenator (Mini-max Plus; Medtronic Inc., Anaheim, CA) and a non-pulsatile roller
pump (model 10.10.00; Stôckert Instruments; Munich, Germany) will be used. Venting of the
left heart will be performed with a left atrial vent inserted through a small incision at the
interatrial septum. Priming fluids consist of lactated Ringer's solution supplemented with
heparin. Fresh whole blood was added to the priming solution in appropriate amounts to
achieve a hematocrit of 20% to 22% during CPB ( cardiopulmonary bypass). Moderate hypothermia
(26°C to 28°C) will be used during CPB.
After cardiac repair the patient will be weaned from CPB. protamine will be given 3-4 mg/kg
to reverse heparin. The control group will not subjected to ultrafiltration and the
ultrafiltration group will be subjected to conventional ultrafiltration guided by hematocrit
level 28%.
Blood transfusion on bypass will be guided by hemoglobin level in ABG (arterial blood gases)
to keep HB% (hemoglobin) above 7mg/dl. Transfusion of blood products will be guided by
clinical state of patient.
Assessment of extra vascular lung water busing lung ultrasound. Lung ultrasound will be
performed to diagnose EVLW (extravascular lung water). A M. turbo sonosite ultrasound system
with pediatric linear probe (frequency 13-6 MHz( megahertz); Fujifilm, sonosite, inc. USA)
will be used. Chest ultrasound will be performed using the 12 reg ions method. Intercostals
spaces on each side will be examined anteriorly (midclavicular line), laterally (anterior
axillary line) and posteriorly (posterior axillary line) (2).
Four ultrasound aeration patterns: a. Normal aeration (N): 0 score ; line sliding sign
associated with respiratory movement or less than 3 B lines ; b. Moderate loss of lung
aeration: score 1 ; a clear number of multiple visible B-lines with horizontal spacing
between adjacent B lines ≤ 7 mm (B7 lines) c. Severe loss of lung aeration: score 2; multiple
B lines fused together that were difficult to count with horizontal spacing between adjacent
B lines ≤ 3 mm (B3 lines); and d. Pulmonary consolidation: score 3; hypoechoic lung tissue,
accompanied by dynamic air bronchogram.
The final LUS (lung ultrasound score) of the patient was the sum of each regional ultrasound
score (ranging from 0 to 36).
The lung ultrasound score will be recorded at baseline and at end of surgery. ABGs will be
taken to measure p/f ratio. Hemodynamic (HR and MAP) will be recorded.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05637424 -
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