: External Shunt Versus Internal Shunt for Off Pump Glenn

Study Overview
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Brief Summary
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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
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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.

Official Title
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External Shunt Versus Internal Shunt for Off Pump Glenn (Original Article)

Conditions
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Cerebral Ischemia

Intervention / Treatment
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* Procedure: Internal shunt
* Procedure: External shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: single-ventricle lesions, good sized branch pulmonary arteries (Magoon's index > 1.5), PA pressures < 20 mmHg, So2 < 80%, age range from (6 months-5years) weight range from (6-21) kg, -All these patients had adequate atrial septal defects and none of these patients required any intra cardiac repair.- Exclusion Criteria: previous cardiac operation, known intracranial pathology, neurologic disease craniofacial anomalies.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, randomized comparative study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Internal shunt<br>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. | Procedure: Internal shunt<br>* 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.<br>* Other names: Venoatrial shunt;|
| Active Comparator: External shunt<br>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 | Procedure: External shunt<br>* 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<br>* Other names: Jagulo femoral shunt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean SVC Pressure | Measurment of superior vena cava pressure during off pumb Glenn | during SVC clamping procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean ABP | Measurment of mean arterial blood preassure during off bumb Glenn | baseline, pre-intervention during the intervention procedure immediately after the intervention | 
| cerebral perfusion pressure | CPP= MABP - CVP | baseline, pre-intervention during the intervention procedure immediately after the intervention | 
| Mean SVC clamp time | Duration of SVC during off pump glenn with either Internal or external shunt | during SVC clamping procedure |