: External Shunt Versus Internal Shunt for Off Pump Glenn
Condition: Cerebral Ischemia
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      A prospective, randomized comparative study where investigators present results of off pump
      bidirectional Glenn operation done using either a venoatrial shunt or external shunt to
      decompress superior vena cava during clamping.
    

Detailed description: 
      The bidirectional Glenn shunt (BDG) is performed for cyanotic congenital heart defects, with
      single-ventricle pathology . The BDG is usually performed with cardiopulmonary bypass (CPB)
      with its associated complications. The conduct of this operation without CPB can be
      associated with elevation of superior vena caval (SVC) pressure that may lead to neurological
      damage.

      However, the safety of performing BDG without CPB reported by many authors but with some
      decompression techniques of the SVC at the time of clamping

      Objective: investigators present results of off pump bidirectional Glenn operation done using
      either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.

      Design A prospective, randomized comparative study Setting: Single tertiary care cardiac
      center Participants 30 patients with functional single ventricle who will go off pump
      bidirectional Glenn.

      Interventions: The patients will be randomly assigned into two groups: Group I (n = 15),
      where it will be done with a veno-atrial shunt(internal), and Group II (n = 15), where it
      will be done with an external shunt. All patients will go a complete neurological examination
      both preoperatively as well as postoperatively Intraoperative data will be collected and
      analyzed at the following time points: pre-clamping (post induction), during clamping and
      after de-clamping of SVC. variables such as arterial oxygen saturation (SaO2), systolic blood
      pressure (SBP), mean arterial blood pressure (MAP), diastolic blood pressure (DBP), and
      hematocrit, CVP, SVC pressure, cerebral perfusion pressure (CPP= MAP-CVP), PaO2, PaCO2 and
      ScvO2 will be analyzed.

      Postoperatively, the patients will be stabilized in the intensive care unit (ICU) and after
      monitoring the SVC pressure for 12 h, the internal jugular vein cannula will be removed to
      prevent any jugular vein thrombosis. The patients will start aspirin (5 mg/kg/day), which
      will be continued indefinitely.
    

Intervention name(s): Internal shunt; External shunt
Intervention type(s): Procedure; Procedure
Intervention description(s): glenn with internal shunt (veno-atrial shunt) where the surgeon established a shunt between distal SVC and the right atrium, Establishing a veno-atrial shunt.; Glenn with external shunt where the anesthesiologist connected the internal Jagular venous cannula which represent the SVC with the main lumen of the femoral cannula which represent the IVC through long venous extension
Other intervention name(s): Venoatrial shunt; Jagulo femoral shunt
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized comparative study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment