: External Shunt Versus Internal Shunt for Off Pump Glenn

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05294718
Study type	Interventional
Source	Kasr El Aini Hospital
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2017
Completion date	August 1, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.