: External Shunt Versus Internal Shunt for Off Pump Glenn

NCT ID: NCT05294718

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2022-08-01

Brief 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.

Conditions

Cerebral Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Internal shunt

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.

Group Type: ACTIVE_COMPARATOR

Internal shunt

Intervention Type: PROCEDURE

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.

External 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

Group Type: ACTIVE_COMPARATOR

External shunt

Intervention Type: PROCEDURE

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

Interventions

Internal shunt

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.

Intervention Type: PROCEDURE

External 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

Intervention Type: PROCEDURE

Other Intervention Names

Venoatrial shunt; Jagulo femoral shunt

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Mohamed Elhaddad

Lecturer of Anesthesia, ICU and Pain managment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-103-2013

Identifier Type: -

Identifier Source: org_study_id