Aim of Work:
The aim of this randomized, double-blinded, study is to compare between three modes of
ventilation during cardiopulmonary bypass in pediatric patients with pulmonary hypertension
undergoing corrective cardiac surgeries.
The hypothesis of the present study is that high frequency low volume positive pressure
ventilation is better than continous positive airway pressure (CPAP)and passive deflation on
direct PAP (pulmonary artery pressure ) reading and immediate oxygenation after
cardiopulmonary bypass CPB in pediatric patients undergoing cardiac surgeries for congenital
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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The disease, disorder, syndrome, illness, or injury that is being studied.
The patients will be randomized in a double blinded fashion to get enrolled into 3 equal
groups: Group HFPPV patients (n = 8) will receive high frequency positive pressure
ventilation during cardiopulmonary bypass at tidal volume 2 ml/kg and respiratory rate 80,
whereas Group CPPV patients (n = 8 ) will receive continuous positive airway pressure of 10
cmH2O during the bypass, while Control group patients (n = 8 ) will be disconnected from the
ventilation (passive deflation) .The study will be conducted in the pediatric cardio-thoracic
operation rooms in AbulReesh Hospital in Cairo University.
Advanced Monitoring where Naso-pharyngeal temperature probe will be placed, a Central venous
catheter to monitor central venous pressure and an arterial cannula to monitor invasive blood
pressure after that, standard cardiopulmonary bypass technique will be used in all patients.
Before aortic cannulation, patients will receive IV heparin 400 U.kg-1 aiming to produce
activated clotting time ACT value > 400 sec. A membrane oxygenator (minimax plus; Medtronics
Inc.) will be used during cardiopulmonary bypass. Priming solution in the form of iso-tonic
saline solution supplemented with heparin added to fresh whole blood in appropriate amounts
to achieve a haematocrit 20-25% during CPB will be used. Furosemide in a dose of 1 mg/kg/min
will be given to all patients. Venting of left heart will be performed with a left atrial
vent inserted through a small incision at the inter-atrial septum. Anesthesia during CPB will
be given by Sevoflurane administrated via a vaporizer inserted into the oxygenator gas supply
with a constant gas flow 3 liter/min. A non-pulsatile roller pump (model10.10.00; Stocket
instruments; Munich, Germany) will be used and the pump flow will be adjusted at 2.4 to 2.6
L/min /m2 during the normothermic period targeting mean arterial blood pressure between 40
and 60 mmHg. Moreover, all patients will receive milrinone loading dose of 50mcg/kg/min the
maintanence 0.5-1 mcg/kg/min and or adrenaline 0.02-0.1 mcg/kg/min will be utilized to
facilitate weaning from CPB.
After sternotomy and direct exposure of the pulmonary artery, the pulmonary artery systolic
pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the
surgeon into the pulmonary artery, was calculated and recorded immediately after sternotomy,
after aortic clamp removal, and 10 minutes after initiation of protamine infusion).
After application of aortic cross clamp and administration of cold blood cardioplegia
solution (Saint Thomas cardioplegic solution) 40 ml/Kg to be followed by doses of 10ml/Kg
every 30 minutes.), Group A patients will receive high frequency low volume positive pressure
ventilation (HFPPV) during cardiopulmonary bypass at tidal volume Vt 2 ml/kg and respiratory
rate RR 80, whereas Group B patients (n =8 ) will receive continous positive airway pressure
CPAP of 10 cmH2O, and group C patients will be disconnected from the ventilator (passive
Finally, Lung Ultrasound Score will be obtained after induction of anesthesia and at the end
of surgery after chest closure, The duration of mechanical ventilation, length of stay in the
intensive care unit and immediate post bypass oxygenation as well as the requirement for
inotropic and vaso-tropic support during the first 24 hours study period will be recorded for
all patients. Lung ultrasound protocol:
Lung ultrasound will be performed after induction of anesthesia and at the end of the
operation with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China). Patients
will be investigated in supine position by a well-trained physician recording five seconds
videos that will be assessed by two different observers who will be blinded from the patient
data. Lung ultrasound will be assessed for the presence of B lines.
will receive high frequency positive pressure ventilation during cardiopulmonary bypass at tidal volume 2 ml/kg and respiratory rate 80. Lung ultrasound will be done at the beginning and end of surgery
will receive continuous positive airway pressure of 10 cmH2o during the bypass. Lung ultrasound will be done at the beginning and end of surgery
No Intervention: Control
will be disconnected from the ventilation (passive deflation). Lung ultrasound will be done at the beginning and end of surgery.Lung ultrasound will be done at the beginning and end of surgery
Diagnostic Test: - lung ultrasound
Lung ultrasound will be performed after induction of anesthesia and at the end of the operation with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Cairo University Pediatric Hospitals
Giza, الجيزة, 12555
mostafa El berry